Emollient-treated absorbent interlabial application

ABSTRACT

Absorbent devices, and more particularly absorbent devices that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both, that have a emollient composition on their body-contacting surface are disclosed. The interlabial device has a body-contacting surface that is pre-moistened or pre-treated with an emollient to prevent drying of the wearer&#39;s labial tissue and to reduce friction of the structure against the wearer&#39;s labial tissue. The absorbent device is preferably capable of maintaining contact with the inside surfaces of the wearer&#39;s labia majora when worn. The emollient composition comprises a plastic or fluid emollient such as mineral oil, petrolatum and/or polysiloxane, an immobilizing agent such as a fatty alcohol or wax to immobilize the emollient on the body-contacting surface of the device, and optionally a hydrophilic surfactant to improve wettability of the coated surface. Because the emollient is substantially immobilized on the surface of the absorbent device, less emollient is required to impart the desired therapeutic or protective emollient coating benefits.

FIELD OF THE INVENTION

[0001] The present invention relates to an absorbent device that is worninterlabially for catamenial purposes, incontinence protection, or both.More particularly, the present invention relates to an interlabialdevice that is pre-moistened or pre-treated with an emollient forimproved comfort.

BACKGROUND OF THE INVENTION

[0002] All manner and variety of absorbent articles configured for theabsorption of body fluids such as menses, urine and feces are, ofcourse, well known. With respect to feminine protection devices, the arthas offered two basic types; sanitary napkins have been developed forexternal wear about the pudendal region while tampons have beendeveloped for internal wear within the vaginal cavity for interruptionof menstrual flow therefrom. Such tampon devices are disclosed in U.S.Pat. No. 4,412,833, entitled “Tampon Applicator”, issued to Weigner, etal. on Nov. 1, 1983, and U.S. Pat. No. 4,413,986, entitled “TamponAssembly With Means For Sterile Insertion”, issued to Jacobs on Nov. 8,1983.

[0003] Hybrid devices which attempt to merge the structural features ofthe sanitary napkins and the tampons into a single device have also beenproposed. Such hybrid devices are disclosed in U.S. Pat. No. 2,092,346,entitled “Catamenial Pad”, issued to Arone on Sep. 7, 1937, and U.S.Pat. No. 3,905,372, entitled “Feminine Hygiene Protective Shield”,issued to Denkinger on Sep. 16, 1975. Other less intrusive hybriddevices are known as labial or interlabial sanitary napkins and arecharacterized by having a portion which at least partially resideswithin the wearer's vestibule and a portion which at least partiallyresides external of the wearer's vestibule. Such devices are disclosedin U.S. Pat. No. 2,662,527, entitled “Sanitary Pad”, issued to Jacks onDec. 15, 1953, and U.S. Pat. No. 4,631,062, entitled “Labial SanitaryPad”, issued to Lassen, et al. on Dec. 23, 1986.

[0004] Interlabial pads have the potential to provide even greaterfreedom from inconvenience because of their small size and reduced riskof leakage. Numerous attempts have been made in the past to produce aninterlabial pad which would combine the best features of tampons andsanitary napkins while avoiding at least some of the disadvantagesassociated with each of these types of devices. Examples of such devicesare described in U.S. Pat. No. 2,917,049 issued to Delaney on Dec. 15,1959, U.S. Pat. No. 3,420,235 issued to Harmon on Jan. 7, 1969, U.S.Pat. No. 4,595,392 issued to Johnson, et al. on Jun. 17, 1986, and U.S.Pat. No. 5,484,429 issued to Vukos, et al. on Jan. 16, 1996. Acommercially available interlabial device is FRESH 'N FIT® PADETTEinterlabial product which is marketed by Athena Medical Corp. ofPortland, Oreg. and described in U.S. Pat. Nos. 3,983,873 and 4,175,561issued to Hirschman on Oct. 5, 1976 and Nov. 27, 1979, respectively.

[0005] However, many of these devices have not met with great commercialsuccess. There are drawbacks associated with all of the above products.The devices described in these patents are believed to potentially beuncomfortable to wear due to frictional discomfort associated withrubbing of the product against the labial walls and sticking of thesurfaces of the device to the labial walls. Furthermore, the frictionaldrag and sticking of the body-contacting surface of such devices againstthe labia can prevent these devices from being properly inserted,leading to discomfort.

[0006] The problem of drying of a female wearer's labial vestibule areahas been discussed in the patent literature. For example, U.S. Pat. No.4,846,824 issued to Lassen, et al. on Jul. 11, 1989, is directed to alabial sanitary pad that has a “physiologically hydrous” cover (that is,a cover material supposedly designed to “maintain a moist interfacebetween the tissues of the vestibule and the pad”). Types of covermaterials specified in the Lassen, et al. patent include a spunlacedpolyester fiber nonwoven and a rayon cover. The Lassen, et al. patentstates that the covers can be provided with various “coatings” tomaintain the physiologically hydrous feature, but no specific coatingsappear to be disclosed.

[0007] European Patent Application EP 0 692 263 A2, “Method of reducingthe coefficient of friction of absorbent products and wax coatedproducts produced thereby”, is directed to lubricated absorbent productshaving a coating of a small amount of high molecular weight solid waxysubstance which has a softening point above body temperature. However,there are drawbacks associated with the use of high molecular weightmaterials for this purpose. High molecular weight materials will not beas soothing or lotion-like to the wearer's skin as lower molecularweight materials. In addition, high molecular weight materials will notbe capable of transferring to the wearer's skin to provide skin carebenefits. High molecular weight waxes can also become brittle and tendto flake or chip off an absorbent article due to their lack offlexibility if the absorbent article is of a type that is required toflex and bend. Further, if the softening point of such materials ishigher than room temperature, application of such materials to anabsorbent article will be more difficult, and will require that thematerial be heated in order to coat an absorbent article with such amaterial.

[0008] A vaginal moisture balanced tampon and process is disclosed inEuropean Patent Application 0 685 215 A1. However, the interlabialdevice of the present invention is not intended to be worninter-vaginally as a tampon.

[0009] Thus, a need exists for an interlabial device that is small insize and that can be easily inserted and that provides protectionagainst incontinence, menstrual discharges, and discharges of bodilyexudates throughout a great range of wearer motions. A need exists foran interlabial device which is absorbent, has a reduction in frictionaldiscomfort associated with rubbing of the product against the labialwalls and sticking of the surfaces of the device to the labial walls. Aneed also exists for an interlabial device that has a reduced tendencyto dry the inside surface of the wearer's labia.

[0010] Therefore, it is an object of the present invention to provide aninterlabial device that is small in size and that can be easily insertedand that provides protection against incontinence, menstrual discharges,and discharges of bodily exudates throughout a great range of wearermotions.

[0011] It is another object of the present invention to provide aninterlabial device which is absorbent, but has a reduction in frictionaldiscomfort associated with rubbing of the product against the labialwalls and sticking of the surfaces of the device to the labial walls.

[0012] It is another object of the present invention to provide aninterlabial device that has a reduced tendency to dry the inside surfaceof the wearer's labia.

[0013] It is still another object of the present invention to provide aninterlabial device that can be inserted into the space between thewearer's labia with less friction so that it will more easily be fullyinserted into the desired wearing position.

[0014] These and other objects of the present invention will become morereadily apparent when considered in reference to the followingdescription and when taken in conjunction with the accompanyingdrawings.

SUMMARY OF THE INVENTION

[0015] This invention relates to absorbent devices, and moreparticularly to an absorbent device that is insertable into theinterlabial space of a female wearer for catamenial purposes,incontinence protection, or both. The interlabial device has abody-contacting surface (in particular, a surface contacting the labialvestibule) which is pre-treated with an emollient to prevent drying ofthe wearer's labial tissue and to reduce friction of the structureagainst the wearer's labial tissue.

[0016] The absorbent interlabial device of the present invention, in onepreferred embodiment, comprises a main absorbent portion and a pair offlexible extensions joined to the main absorbent portion. The mainabsorbent portion preferably comprises an upper portion and a lowerportion opposed to the lower portion. The upper portion faces toward thevestibule floor of the wearer during insertion of the absorbent deviceinto the wearer's interlabial space and during use. That is, the upperportion is positioned furthest inward into the space between thewearer's labia thus leading the lower portion of the absorbent deviceduring insertion. Upon insertion, the lower portion is less fullyinserted into the wearer's interlabial space than the upper portion andthe lower portion faces away from the floor of the vestibule of thewearer. The flexible extensions preferably extend downwardly andoutwardly from the upper portion of the main absorbent portion and arejoined to the same. The flexible extensions are preferably capable ofmaintaining contact with inside surfaces of the wearer's labia andcovering a substantial portion of the same.

[0017] At least a portion of said body-contacting surface of theinterlabial device comprises an effective amount of an emollient coatingwhich is preferably semisolid or solid at ambient temperature, 68° F.(or 20° C.). The coating preferably comprises a substantially water-freeemollient having a plastic or fluid consistency at 20° C. and comprisinga member selected from the group consisting of petroleum-basedemollients, fatty acid ester emollients, alkyl ethoxylate emollientsand/or polysiloxane emollients, and mixtures thereof In a preferredembodiment, the emollient contains about 5% or less water and comprisesa petroleum based emollient selected from the group consisting ofmineral oil, petrolatum, and mixtures thereof In an alternate preferredembodiment, the emollient emollient contains about 5% or less water andcomprises a polysiloxane emollient.

[0018] The emollient-treated interlabial device provides a reduction infrictional discomfort associated with rubbing of the product against thelabial walls and sticking of the surfaces of the device to the labialwalls. The emollient-treated interlabial device also has a reducedtendency to dry the inside surface of the wearer's labia. Theinterlabial device, because of the presence of the emollient, can beinserted into the space between the wearer's labia with less friction sothat it will more easily be fully inserted into the desired wearingposition.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] While the specification concludes with claims particularlypointing out and distinctly claiming the subject matter which isregarded as forming the present invention, it is believed that theinvention will be better understood from the following description takenin conjunction with the accompanying drawings, in which:

[0020]FIG. 1 is a perspective view of a preferred embodiment of theabsorbent interlabial device of the present invention.

[0021]FIG. 2 is an end view of the absorbent device shown in FIG. 1.

[0022]FIG. 3 is an end view of a variation of the preferred embodimentshown in FIG. 2.

[0023]FIG. 4 is an end view of an alternative preferred embodiment ofthe present invention having a pleated main absorbent portion.

[0024]FIG. 5 is an end view of an alternative preferred embodiment ofthe present invention showing a main absorbent portion having a multiplelayer structure.

[0025]FIG. 6 is a cross-sectional view of a wearer's body surroundingand including the wearer's labia majora and labia minora showing how aprior art interlabial device might fit in the space between the wearer'slabia when the wearer is standing.

[0026]FIG. 7 is a cross-sectional view of the same region of thewearer's body shown in FIG. 6 showing how the prior art device might fitwhen the wearer squats.

[0027]FIG. 8 is a cross-sectional view of the same region of thewearer's body shown in FIG. 7 showing the flexible extensions of thepresent invention covering the wearer's fingertips as the absorbentdevice of the present invention is inserted into the wearer'sinterlabial space.

[0028]FIG. 9 is a cross-sectional view of the same region of thewearer's body shown in FIG. 6 showing how the absorbent interlabialdevice of the present invention fits when the wearer is standing.

[0029]FIG. 10 is a cross-sectional view of the same region of thewearer's body shown in FIG. 7 which shows how the absorbent interlabialdevice of the present invention fits when the wearer squats.

[0030]FIG. 11 is a sectional view of the wearer's body showing how ahypothetical prior art interlabial device that is not treated with anemollient may fit.

[0031]FIG. 12 is a sectional view of the wearer's body showing how theemollient-treated interlabial device of the present invention may fit.

[0032]FIG. 13 is a schematic perspective view of the Three Point BendTest apparatus.

[0033]FIG. 14 is a plan view of an apparatus suitable for flushabilitydetermination according to the method described in the TEST METHODSsection below.

[0034]FIG. 15 is a cross-section of the flushability apparatus of FIG.14 taken along line 15-15 thereof

DETAILED DESCRIPTION OF THE INVENTION

[0035] A. The Absorbent Device.

[0036] The present invention is directed to an interlabial absorbentarticle (or “absorbent interlabial structure” or “absorbent interlabialdevice”) which has a body-contacting surface that is pre-lubricated toprevent drying of the wearer's labial tissue and to reduce friction ofthe structure against the wearer's labial tissue. FIGS. 1-3 show onepreferred embodiment of the interlabial absorbent structure of thepresent invention, interlabial device 20. The present invention,however, can be in many other forms, and is not limited to a structurehaving the particular configuration shown in the drawings.

[0037] As used herein the term “absorbent interlabial device” refers toa structure which has at least some absorbent components, and isspecifically configured to reside at least partially within theinterlabial space of a female wearer during use. Preferably, more thanone-third, more preferably more than half of the entire absorbentinterlabial device 20 of the present invention resides within suchinterlabial space, more preferably still substantially the entireabsorbent interlabial device 20 resides within such interlabial space,and most preferably the entire absorbent interlabial device 20 resideswithin such interlabial space of a female wearer during use.

[0038] As used herein, the term “interlabial space” refers to that spacein the pudendal region of the female anatomy which is located betweenthe inside surfaces of the labia majora extending into the vestibule.Located within this interlabial space are the labia minor, the vestibuleand the principal urogenital members including the clitoris, the orificeof the urethra, and the orifice of the vagina. Standard medicalauthorities teach that the vestibule refers to the space boundedlaterally by the inside surfaces of the labia minora and extendinginteriorly to the floor between the clitoris and the orifice of thevagina. Therefore, it will be recognized that the interlabial space asdefined above may refer to the space between the inside surfaces of thelabia majora, including the space between the inside surfaces of thelabia minora also known as the vestibule. The interlabial space forpurposes of the present description does not extend substantially beyondthe orifice of the vagina into the vaginal interior.

[0039] The term “labia” as used herein refers generally to both thelabia majora and labia minora. The labia terminate anteriorly andposteriorly at the anterior commissure and the posterior commissure,respectively. It will be recognized by those skilled in the art thatthere is a wide range of variation among women with respect to therelative size and shape of labia majora and labial minora. For purposesof the present description, however, such differences need not bespecifically addressed. It will be recognized that the disposition ofthe absorbent interlabial device into the interlabial space of a weareras defined above will require placement between the inside surfaces ofthe labia majora without regard to the precise location of the boundarybetween the labia majora and the labia minora for a particular wearer.For a more detailed description of this portion of the female anatomy,attention is directed to Gray's Anatomy, Running Press 1901 Ed. (1974),at 1025-1027.

[0040] The absorbent interlabial device 20 shown in FIG. 1 has alongitudinal centerline L which runs along the “x” axis shown in FIG. 1.The term “longitudinal”, as used herein, refers to a line, axis ordirection in the plane of the interlabial device 20 that is generallyaligned with (e.g., approximately parallel to) a vertical plane whichbisects a standing wearer into left and right body halves when theinterlabial device 20 is worn. The terms “transverse,” “lateral,” or “ydirection” as used herein, are interchangeable, and refer to a line axisor direction that is generally perpendicular to the longitudinaldirection. The lateral direction is shown in FIG. 1 as the “y”direction. The “z” direction, shown in FIG. 1, is a direction parallelto the vertical plane described above. The term “upper” refers to anorientation in the z-direction toward the wearer's head. “Lower” ordownwardly is toward the wearer's feet.

[0041] As shown in FIG. 1, the interlabial device 20 comprises a mainabsorbent portion (or “central absorbent”) 22, and a pair of flexibleextensions 24 joined to the main absorbent portion 22. The mainabsorbent portion 22 should be at least partially absorbent. The mainabsorbent portion 22 may comprise non-absorbent portions, such as aliquid impervious barrier to prevent absorbed exudates from leaking outof the main absorbent portion 22. The main absorbent portion 22comprises an upper portion 26 and a lower portion 28 that is opposed tothe upper portion. The flexible extensions 24 are joined to the upperportion 26 of the main absorbent portion. In use, the upper portion 26is positioned furthest inward into the wearer's interlabial space. Theinterlabial device has a body-facing (or “body-contacting”) surface 20Aand a back surface 20B. The body-facing surface 20A can be comprised ofat least a portion of the absorbent portion 22, at least a portion ofthe flexible extensions 24, or at least a portion of both.

[0042] The interlabial device 20 should be of a suitable size and shapethat allows at least a portion thereof to fit comfortably within thewearer's interlabial space and to cover the wearer's vaginal orifice,and preferably also the wearer's urethra. The interlabial device 20 atleast partially blocks, and more preferably completely blocks andintercepts the flow of menses, urine, and other bodily exudates from thewearer's vaginal orifice and urethra.

[0043] The size of the interlabial device 20 is also important to thecomfort associated with wearing the device. In the preferred embodimentshown in FIG. 1, the main absorbent portion 22 of the interlabial device20 has a length as measured along the longitudinal centerline, L, ofbetween about 35 mm and about 100 mm. Preferably, the length of theinterlabial device 20 is between about 45 mm and about 55 mm, and morepreferably, is about 49 mm. The caliper (or width) of the main absorbentportion 22 of the interlabial device as measured in the transversedirection (or “y”-direction) is preferably less than or equal to about 8mm, more preferably the caliper is between about 3 mm and about 6 mm,most preferably, the caliper is about 4.5 mm. Caliper measurements givenherein were measured using an AMES gage with a 0.25 psi (gauge) load anda 0.96 inch diameter foot. Those skilled in the art will recognize thatif a 0.96 inch diameter foot is not appropriate for a particular samplesize, the foot size may be varied while the load on the gauge isaccordingly varied to maintain a confining pressure of 0.25 psi (gauge).The height (or “z”-direction dimension) of the main absorbent portion 22is preferably between about 8 mm and about 35 mm, and more preferably isabout 20 mm.

[0044] The interlabial device 20 is preferably provided with sufficientabsorbency to absorb and retain the exudates discharged from thewearer's body. The capacity of the product, however, is dependent atleast partially upon the physical volume of the absorbent interlabialdevice 20, particularly the main absorbent portion 22 thereof The mainabsorbent portion 22 preferably has a capacity of at least about 1 g of0.9% by weight saline solution, and may have a capacity of up to about30 g by using absorbent gels or foams that expand when wet. Capacitiesmay typically range from about 2 to about 20 grams, for saline. Inparticularly preferred embodiments, the interlabial device has acapacity of greater than or equal to about 2.5 grams of saline, and morepreferably greater than or equal to about 4 grams of saline. Thoseskilled in the art will recognize that the capacity for absorption ofbody exudates such as menses will typically be smaller than thecapacities given above for absorption of saline. A method for measuringabsorbent capacity is described in the Test Methods section, below.Since the interlabial space can expand, larger volumes can be stored inthe interlabial space, if the fluid is stored as a gel, which adjusts tothe body pressures. Additionally, if the absorbent interlabial device 20does not reside completely within the wearer's interlabial space, someof the absorbed exudates may be stored externally to the wearer'sinterlabial space.

[0045] The main absorbent portion 22 of the preferred embodiment shownin FIGS. 1-3 may comprise any suitable type of absorbent structure thatis capable of absorbing and/or retaining liquids (e.g. menses and/orurine). The main absorbent portion 22 may be manufactured in a widevariety of shapes. Non-limiting examples include ovoid, trapezoidal,rectangular, triangular, cylindrical, hemispherical or any combinationof the above. The main absorbent portion 22 may, likewise, bemanufactured and from a wide variety of liquid-absorbent materialscommonly used in absorbent articles such as comminuted wood pulp whichis generally referred to as airfelt. Examples of other suitableabsorbent materials include creped cellulose wadding; meltblown polymersincluding coform; chemically stiffened, modified or cross-linkedcellulosic fibers; synthetic fibers such as crimped polyester fibers;peat moss; tissue including tissue wraps and tissue laminates; absorbentfoams; absorbent sponges; superabsorbent polymers; absorbent gellingmaterials; or any equivalent material or combinations of materials, ormixtures of these. Preferred absorbent materials comprise foldedtissues, woven materials, nonwoven webs, needle punched rayon, andlayers or pieces of foam. The main absorbent portion 22 may comprise asingle material or a combination of materials, such as a wrapping layersurrounding a central wadding comprised of a different absorbentmaterial.

[0046] In the preferred embodiment shown in FIG. 1, the main absorbentportion 22 is formed of a soft absorbent material such as rayon fibersor other suitable natural or synthetic fibers or sheeting. The mainabsorbent portion 22 shown in FIG. 1 is generally of an ovoid crosssectional shape as shown in FIG. 2. The main absorbent portion 22 of theembodiment shown in FIGS. 1 and 2 comprises an upper portion 26 with alarger transverse sectional dimension relative to that of the lowerportion 28. The upper portion 26 is preferably integral with the lowerportion 28. In less preferred embodiments, however, the upper portion 26and lower portion 28 may comprise separate elements joined together byany suitable means know in the art. In the preferred embodiment shown inFIGS. 1 and 2, the juncture of the upper portion 26 and lower portion 28of the main absorbent portion 22 comprises a substantially abrupt changein the transverse dimension thereby forming a shoulder-likeconfiguration at such juncture. In the preferred embodiment shown inFIGS. 1 and 2, the juncture of the upper portion 26 and lower portion 28of the main absorbent portion 22 is formed by stitching 34.

[0047] In a variation of the preferred embodiment described above andshown in FIGS. 1 and 2, the upper portion 26 may have a smallertransverse sectional dimension relative to the transverse sectionaldimension of the lower portion 28. An absorbent interlabial device 20having such a configuration is shown in FIG. 3.

[0048] The main absorbent portion 22 can be made by any suitableprocess. U.S. Pat. No. 4,995,150 issued to Gerstenberger et al. on Feb.26, 1991 and U.S. Pat. No. 4,095,542 issued to Hirschman on Jun. 20,1978 describe methods for making absorbent devices which are suitablefor use as the main absorbent portion 22 of the absorbent interlabialdevice 20 shown in FIGS. 1-3.

[0049] As shown in FIGS. 1-3, a preferred embodiment of the absorbentinterlabial device 20 also comprises a pair of flexible extensions 24which are joined to the upper portion 26 of the main absorbent portion22 of the absorbent interlabial device 20. In the preferred embodimentshown in FIGS. 1-3, the flexible extensions 24 are generally rectangularin shape. Other shapes are also possible for the flexible extensions 24such as semi-circular, trapezoidal, or triangular. The flexibleextensions 24 preferably are from about 30 mm to about 160 mm in length,more preferably from about 45 mm to about 130 mm in length, and mostpreferably from about 50 mm to about 115 mm in length. While theflexible extensions 24 can have a length (measured in the x-direction)which is shorter than the main absorbent portion 22, preferably theyhave a length which is the same as or longer than the main absorbentportion 22 of the absorbent interlabial device 20. The width of eachflexible extensions refers to the distance from the attachment offlexible extension 24 to the main absorbent portion 22 (or the proximalend 24A of the flexible extension 24) to the distal end (or free end)24B of the flexible extension 24. The width of the flexible extensions24 is preferably about equal to or greater than the height of the mainabsorbent portion as described above. The caliper of the flexibleextensions is preferably less than or equal to about 3 mm, morepreferably less than or equal to about 2 mm, and most preferably lessthan or equal to about 1 mm. Ideally, the caliper of the flexibleextensions 24 and the main absorbent portion 22 are selected such thatthe caliper of the overall absorbent interlabial structure 20 is lessthan or equal to about 8 mm.

[0050] The flexible extensions 24 may be constructed of a tissue layer.A suitable tissue is an airlaid tissue available from Fort Howard TissueCompany of Green Bay, Wis. and having a basis weight of 35 lbs./3000 sq.ft. Another suitable airlaid tissue is available from Merfin HygenicProducts, Ltd., of Delta, British Columbia, Canada, having a basisweight of 61 g/m² and having the designation grade number 176. Stillanother suitable material is an airlaid cotton batt such as that sold ascosmetic squares by Revco Stores, Inc. of Twinsberg, Ohio. The flexibleextensions 24 may optionally be backed with a layer of material which isimpervious or semi-pervious to body exudates such as, polyethylene,polypropylene, or a polyvinylalchohol.

[0051] In the preferred embodiments shown in FIGS. 1-3 the pair offlexible extensions 24 may comprise a single sheet of material extendingto either side of the longitudinal centerline L of the main absorbentportion 22 of the absorbent interlabial device 20. Alternatively, thepair of flexible extensions 24 may comprise separate sheets of materialindependently joined to the upper portion 26 of the main absorbentportion 22. Preferably, the flexible extensions 24 are arrangedsymmetrically about the longitudinal centerline L of the main absorbentportion 22. The flexible extensions 24 are joined to the upper portion26 of the main absorbent portion 22 of the absorbent interlabial device20. Most preferably, the flexible extensions are joined to the topsurface of the upper portion 26 of the main absorbent portion 22, orwithin about 3 mm of the top surface of the main absorbent portion 22.

[0052] The term “joined”, as used herein, encompasses configurations inwhich an element is directly secured to another element by affixing theelement directly to the other element; configurations in which theelement is indirectly secured to the other element by affixing theelement to intermediate member(s) which in turn are affixed to the otherelement; and configurations in which one element is integral withanother element; i.e., one element is essentially part of the otherelement.

[0053] The flexible extensions 24 may be joined to the upper portion 26of the main absorbent portion 22 by any variety of means. For example,in the preferred embodiments shown in FIGS. 1-3 the flexible extensions24 may be joined to the upper portion 26 using any suitable adhesive 36centered about the longitudinal centerline L of the main absorbentportion 22 (i.e., on opposite sides of the longitudinal centerline L).The adhesive 36 may extend continuously along the length of the mainabsorbent portion 22 or it may be applied in a “dotted” fashion atdiscrete intervals. Alternatively, the flexible extensions 24 may bejoined to the upper portion 26 of the main absorbent portion 22 bystitching (such as with cotton or rayon thread), thermally bonding,fusion bonding, or any other suitable means known in the art for joiningsuch materials.

[0054] As shown in FIGS. 1-3, the flexible extensions 24 are attached tothe upper portion 26 of the main absorbent portion 28. The flexibleextensions 24 extend downwardly and outwardly from the main absorbentportion 22 to a free end 24B which is unattached to the main absorbentportion. The flexible extensions 24 may be biased slightly outward fromthe main absorbent portion 22 so as to tend to keep the extensions 24 incontact with the inner surfaces of the labia when the absorbentinterlabial device 20 is in place. Additionally, the naturally moistsurfaces of the labia will have a tendency to adhere to the materialcomprising the flexible extensions 24 further tending to keep them incontact with the inner surfaces of the labia. Preferably the flexibleextensions 24 should be capable of motion from a position where the freeends of the flexible extensions 24 lie adjacent to the main absorbentportion 22 (as shown in FIG. 9) to a position where the flexibleextensions 24 extend directly out from the main absorbent portion 22 inthe transverse direction (as shown in FIG. 4).

[0055] The flexible extensions 24 should be of sufficient width andflexibility to allow the flexible extensions to cover the wearer'sfingertips as the absorbent interlabial device 20 is inserted into thewearer's interlabial space. FIG. 8 shows how a wearer may grasp the mainabsorbent portion 22 of the absorbent interlabial device 20 while theflexible extensions 24 remain between the wearer's fingers and her bodyas the device 20 is inserted. Additionally, the flexible extensions 24should be capable of moving with the inner surfaces of the wearer'slabia to maintain contact with the same. The flexible extensions 24 helpkeep the main absorbent portion 22 in place throughout a range of wearermotions such as squatting.

[0056] The flexible extensions may be hydrophilic or hydrophobic. Theflexible extensions 24 may be treated to make them less hydrophilic thanthe main absorbent portion 22. The hydrophilicity of a material isgenerally expressed in terms of its contact angle. Thus, the flexibleextensions 24 may have an advancing contact angle greater than theadvancing contact angle of the main absorbent portion 22, such thatfluid is preferentially directed toward and absorbed by the mainabsorbent portion 22. The flexible extensions 24 may be either absorbentor non-absorbent. Preferably, the flexible extensions 24 have at leastsome absorbency. However, the majority of the fluid absorbed andretained by the absorbent interlabial device 20 will preferablyultimately be retained in the main absorbent portion 22. For a moredetailed description of hydrophilicity and contact angles see thefollowing publications which are incorporated by reference herein: TheAmerican Chemical Society Publication entitled “Contact Angle,Wettability, and Adhesion,” edited by Robert F. Gould, and copyrightedin 1964; and TRI/Princeton Publications, Publication Number 459,entitled “A Microtechnique for Determining Surface Tension,” publishedin April 1992, and Publication Number 468 entitled, “Determining ContactAngles Within Porous Networks,” published in January, 1993, both editedby Dr. H. G. Heilweil.

[0057] The stiffness of both the main absorbent portion 22 and theflexible extensions 24 is important for product comfort. If the mainabsorbent portion 22 is too flexible, the device is not conveniently oreasily placed between the folds of the labia, if it is too stiff, thedevice is uncomfortable and when the user is in a sitting position, theproduct can be forced forward against the clitoris causing discomfort.The main absorbent portion 22 preferably has a stiffness approximatelyequal to that of the products described in U.S. Pat. Nos. 4,995,150 and4,095,542.

[0058] The strength and stiffness of the flexible extensions 24 areimportant characteristics of their design. If the flexible extensions 24have a wet burst strength of about less than or equal to 15 grams, theywill tend to shred and may leave pieces remaining in the wearer'sinterlabial space. Similarly, if the flexible extensions 24 are as stiffas a manila file folder, they do not provide sufficient flexibility todynamically adjust to the motion of the labia. The stiffness of theflexible extensions is measured as a bending resistance. Preferably, theflexible extensions 24 have a bending resistance of less than about 25gm measured using the Three Point Bend Test. More preferably, theflexible extensions 24 have a bending resistance of less than or equalto about 5 gm. A description of the Three Point Bend Test is containedin the Test Methods section, below. The flexible extensions 24 also havean inherent strength, so that during application and wear they do nottear. The wet strength for the flexible extensions should exceed 15grams, and preferably exceeds 150 grams, and most preferably exceeds 300grams. The wet strengths given above are measured using the Wet BurstTest which is described in greater detail in the Test Methods section,below.

[0059] In an alternative preferred embodiment shown in FIG. 4, the mainabsorbent portion 22 of the absorbent interlabial device 20 comprises apleated structure. As shown in FIG. 4, the main absorbent portion 22comprises a folded tissue web. The folded tissue web preferably has astrength greater than that of standard non-wet strength toilet tissue.Preferably, the main absorbent portion 22 comprises a tissue having atemporary wet strength of greater than or equal to about 100 g. In apreferred design this wet strength will decay to about 50% or less ofthe original strength over about 30 minutes.

[0060] As shown in FIG. 4, the tissue web comprising the main absorbentportion 22 is folded into a pleated structure comprising a plurality ofpleats 30 that are arranged in a laterally side-by-side relationship.The tissue web can be folded so that it has any suitable number ofpleats. Preferably, the tissue web is folded so that the overall caliper(i.e., the width) of the main absorbent portion 22 of this embodiment isbetween about 2 mm and less than or equal to about 7 mm.

[0061] The pleats in the folded tissue web are preferably connected orjoined (or retained) in some suitable manner so that the pleatedsections maintain their pleated configuration, and are not able to fullyopen. The pleats can be connected by a variety of means including theuse of thread, adhesives, or heat sealing tissues which contain athermoplastic material, such as, polyethylene. A preferred design usesstitching which joins all of the pleats in the main absorbent portion 22together. Preferably, the main absorbent structure 22 is provided withfive stitch locations (four at the comers and one additional locationapproximately midway between the two lower comers).

[0062] The pleated structure of the main absorbent portion 22 providesseveral advantages. One advantage provided by the pleated structure isthat exudates can penetrate into the pleats of the structure whichpresent a larger and more effective absorbent surface for acquisitionthan a flat surface. This is particularly important when dealing withpotentially viscous fluids and particulate material such as cellulardebris and clots which can plug the surface of the structure presentedto the body. A second advantage of this design is that the caliper (orwidth) of the product can be easily and conveniently controlled byvarying the number of pleats. The structure shown in FIG. 4 alsoprovides a convenient central zone for grasping the product andinserting into the labia, while the body/fingers on the inserting handare protected from contacting the wearer's body.

[0063] As noted above for the preferred embodiment shown in FIGS. 1-3,the flexural rigidity of the main absorbent portion 22 is also importantfor product comfort with the pleated structure shown in FIG. 4. Anadvantage of the pleated structure is that the number, thickness, andtightness of the pleats control the stiffness of the structure.

[0064] The preferred embodiment shown in FIG. 4, preferably has mainabsorbent portion 22 and flexible extension 24 dimensions similar tothose described above for the embodiment shown in FIGS. 1-3. The widthof the main absorbent portion 22 of the interlabial device 20 asmeasured in the transverse direction (y-direction) is preferably betweenabout 2 mm and less than or equal to about 7 mm. Preferably, in apreferred embodiment, the width of the main absorbent portion of theinterlabial device 20 is about 4.5 mm. As shown in FIG. 4, where themain absorbent portion 22 is of a uniform transverse dimension (i.e.,there is no abrupt change in transverse dimension defining the juncturebetween the upper portion and lower portion) the division between theupper portion 26 and lower portion 28 is considered to be at a heightequal to about one-half of the total height of the main absorbentportion 22.

[0065] The pleated design shown in FIG. 4 has the additional benefit ofeasily providing the flexible extensions 24. The extensions 24 cancomprise the same material as the main absorbent portion 22, or they cancomprise a different material. The extensions 24 are joined to the upperportion 26 of the main absorbent portion 22, and most preferably, forthis embodiment, are joined to the top surface of the main absorbentportion 22, or within 2 millimeters of the top surface of the mainabsorbent portion 22. Preferably, in the embodiment shown in FIG. 4, theextensions 24 are integral portions of the main absorbent portion 22(that is, the extensions 24 comprise integral extensions of theabsorbent tissue material that is folded to form the main absorbentportion 22.

[0066] The main absorbent portion 22 and the flexible extensions 24 ofthe absorbent interlabial device 20 shown in FIG. 4 may be constructedfrom any of the materials previously discussed for the embodiments shownin FIGS. 1-3.

[0067] The embodiment shown in FIG. 4 can be provided with variousoptional features. For example, there may be spacers or high loft orvoid zones between the pleats to improve the ability of the device 20 tomove exudates downward. Additionally, the pleats on the portion of theproduct contacting the pelvic floor do not need to be of uniform height.For example, the pleated material in the center might be higher and,therefore, easily collapsed under pressure. Such an arrangement canprovide better fit and/or comfort.

[0068] In another variation of the pleated structure shown in FIG. 4,the main absorbent portion 22 may comprise a plurality of individuallayers 32 joined in a face-to-face relationship. Such a device is shownin FIG. 5. The structure shown in FIG. 5 may have all of the samecharacteristics described above for the pleated structure. One benefitof the use of a plurality of individual layers 32 is that the variouslayers may comprise different materials with different properties orcharacteristics. Each of the flexible extensions 24 may be integral withone of the individual layers 32 or may be joined separately to the upperportion 26 of the main absorbent portion 22. Preferably, the individuallayers 32 are arranged in a side-by-side relationship so that the spacesbetween the layers are oriented in the z-direction (as shown in FIG. 5).

[0069] The interlabial device 20 in any of the embodiments shown in thedrawings may comprise other optional components. For example, theinterlabial device 20 may comprise a topsheet 42 positioned over andjoined to all or a portion of the body-facing surface of the device 20and/or a backsheet 38 positioned over and joined to all or a portion ofits back surface, including the flexible extensions 24. Preferably, if atopsheet 42 and/or a backsheet 38 is used, these components are joinedto at least a portion of the main absorbent portion. In an alternativeembodiment, the main absorbent portion could be at least partiallywrapped by a topsheet 42.

[0070] If a topsheet is used, the topsheet should be compliant, softfeeling, and non-irritating to the wearer's skin. Further, the topsheetshould be liquid pervious permitting liquids (e.g., menses and/or urine)to readily penetrate through its thickness. A suitable topsheet may bemanufactured from a wide range of materials such as woven and nonwovenmaterials; polymeric materials such as apertured formed thermoplasticfilms, apertured plastic films, and hydroformed thermoplastic films;porous foams; reticulated foams; reticulated thermoplastic films; andthermoplastic scrims. Suitable woven and nonwoven materials can becomprised of natural fibers (e.g., wood or cotton fibers), syntheticfibers (e.g., polymeric fibers such as polyester, rayon, polypropylene,or polyethylene fibers) or from a combination of natural and syntheticfibers.

[0071] The topsheet may comprise an apertured formed film. Aperturedformed films are pervious to body exudates and, if properly apertured,have a reduced tendency to allow liquids to pass back through and rewetthe wearer's skin. Thus, the surface of the formed film which is incontact with the body remains dry, thereby reducing body soiling andcreating a more comfortable feel for the wearer. Suitable formed filmsare described in U.S. Pat. No. 3,929,135, entitled “AbsorptiveStructures Having Tapered Capillaries”, which issued to Thompson on Dec.30, 1975; U.S. Pat. No. 4,324,246 entitled “Disposable Absorbent ArticleHaving A Stain Resistant Topsheet”, which issued to Mullane, et al. onApr. 13, 1982; U.S. Pat. No. 4,342,314 entitled “Resilient Plastic WebExhibiting Fiber-Like Properties”, which issued to Radel, et al. on Aug.3, 1982; U.S. Pat. No. 4,463,045 entitled “Macroscopically ExpandedThree-Dimensional Plastic Web Exhibiting Non-Glossy Visible Surface andCloth-Like Tactile Impression”, which issued to Ahr, et al. on Jul. 31,1984; and U.S. Pat. No. 5,006,394 “Multilayer Polymeric Film” issued toBaird on Apr. 9, 1991. The preferred topsheet for the present inventionis the formed film described in one or more of the above patents andmarketed on sanitary napkins by The Procter & Gamble Company ofCincinnati, Ohio as the “DRI-WEAVE” topsheet.

[0072] In a preferred embodiment of the present invention, the bodysurface of the formed film topsheet is hydrophilic so as to help liquidto transfer through the topsheet faster than if the body surface was nothydrophilic so as to diminish the likelihood that menstrual fluid willflow off the topsheet rather than flowing into and being absorbed by themain absorbent portion 22. In a preferred embodiment, surfactant isincorporated into the polymeric materials of the formed film topsheet.Alternatively, the body surface of the topsheet can be made hydrophilicby treating it with a surfactant such as is described in U.S. Pat. No.4,950,254 issued to Osborn.

[0073] If a backsheet is used, the backsheet could be impervious orsemi-pervious to liquids (e.g., menses and/or urine) and is preferablyflexible. As used herein, the term “flexible” refers to materials whichare compliant and will readily conform to the general shape and contoursof the human body. The backsheet prevents the exudates absorbed andcontained in the main absorbent portion 22 from wetting articles whichcontact the absorbent interlabial device 20 such as the wearer'sundergarments. The backsheet also assists the main absorbent portion 22in preventing the wearer's body from being soiled by exudates.Additionally, use of the backsheet may provide an improved surface forthe wearer to grasp between the fingers as the absorbent interlabialdevice 20 is inserted, or as the device is optionally removed with thefingers.

[0074] The backsheet may comprise a woven or nonwoven material,polymeric films such as thermoplastic films of polyethylene orpolypropylene, or composite materials such as a film-coated nonwovenmaterial. Preferably, the backsheet is a polyethylene film having athickness of from about 0.012 mm (0.5 mil) to about 0.051 mm (2.0 mils).An exemplary polyethylene film is manufactured by Clopay Corporation ofCincinnati, Ohio, under the designation P18-0401. The backsheet maypermit vapors to escape from the main absorbent portion 22 (i.e.,breathable) while still preventing exudates from passing through thebacksheet.

[0075] As previously discussed, the absorbent interlabial device 20 ofthe present invention is preferably designed to be placed entirelywithin the interlabial space of a wearer. To use the absorbentinterlabial device 20 of the present invention, the wearer holds themain absorbent portion 22 between her fingers. As shown in FIG. 8, theflexible extensions 24 are spread apart so as to cover the tips of thewearer's fingers during insertion. This feature provides for a hygenicinsertion of the absorbent interlabial device 20 of the presentinvention. The upper portion 26 is inserted first and furthest into theinterlabial space. The wearer may assume a squatting position duringinsertion to assist in spreading the labial surfaces. Once the absorbentinterlabial device 20 is inserted, the flexible extensions 24 tend toadhere to the inside surfaces of the labia. When the wearer is standing,the labial walls close more tightly around the absorbent interlabialdevice 20 as shown in FIG. 9.

[0076]FIG. 12 shows the interlabial device 20 in place in a wearer'sbody. The parts of the wearer's body, W, shown in FIG. 12 are designatedas follows: bladder, B, clitoris, C, urethra, U, labia minora, N, labiamajora, J, vagina, V, vaginal introitus, VI, anus, A, hymenal ring, H,and large intestine, I. The interlabial device 20 is inserted so that itis worn between the wearer's labia minora N and labia majora J andblocks the wearer's vaginal introitus VI without entering the vaginapast the hymenal ring H. That is, the interlabial device 20 lies atleast partially in the vestibule bounded by the labia minora when suchdevice is worn. The interlabial device 20 may also cover, but does notnecessarily occlude, the wearer's urethra U. Preferably, the interlabialdevice 20 covers both the wearer's vaginal introitus VI and the wearer'surethra U. Ideally, the interlabial device 20 is maintained in contactwith as large a portion of the inner surface area of the wearer's labiaminora N and labia majora J as possible. This will ensure that theinterlabial device 20 intercepts as much of the wearer's body exudatesas possible. Preferably, the entire interlabial device 20 is intended tobe worn below the wearer's hymenal ring H.

[0077] The interlabial device 20 may also contain a portion that is wornoutside the wearer's labia majora J. This portion could, for example, beused for storage of body exudates that are transferred from the portionof the interlabial device 20 that is worn between the wearer's labiaminora and labia majora. The portion of the interlabial device 20 thatis worn between the wearer's labia minora and labia majora will, as aresult, will have exudates drained therefrom, and be able to receiveadditional loadings of body exudates.

[0078] The interlabial device 20 is preferably at least partiallyretained in place by exerting a slight laterally outwardly-orientedpressure on the inner surfaces of the wearer's labia minora, labiamajora, or both. Additionally, the product is also held by attraction ofnaturally moist labial surfaces to the tissue comprising the flexibleextensions 24. Optionally, the flexible extensions 24 may be providedwith a bio-compatible adhesive to assist the adhesion of the flexibleextensions 24 to the inside surfaces of the wearer's labia. The strengthof such an adhesive should be selected to assist the absorbentinterlabial device 20 in staying in place, while still allowing forreliable, and comfortable removal of the device from the wearer'sinterlabial space.

[0079] The absorbent interlabial device 20 is believed to differ fromthe prior art in a number of respects. FIG. 6 shows a prior artinterlabial device positioned within the interlabial space when thewearer is standing. When the wearer squats, however, the labia tend toseparate as shown in FIGS. 7 and 10. The prior art device may tend toshift to one side or another in such a situation (as shown in FIG. 7).If the wearer urinates when the prior art device is in the positionshown in FIG. 7, the stream of urine will completely miss the device.The flexible extensions 24 of the present invention, however, areadapted to maintain contact with the inside surfaces of the labia inorder to keep the absorbent interlabial device 20 in proper position (asshown in FIG. 10). This action of the flexible extensions 24 is believedto keep the absorbent interlabial device 20 of the present invention ina position which more consistently blocks the orifice of the urethrathan the prior art device. As a result, the absorbent interlabial device20 of the present invention is believed to be expelled by urination morereliably than the prior art device. As noted previously, the flexibleextensions 24 also cover the wearer's fingertips during insertion (asshown in FIG. 8) thereby providing for a more hygienic insertion than isachieved with the prior art device. Optionally, the absorbentinterlabial device 20 may be removed by grasping the lower portion 28 ofthe main absorbent portion 22 with the fingers. Again, the flexibleextensions 24 continue to cover the fingertips thereby allowing for amore hygienic removal of the absorbent interlabial device 20 than isachieved with the prior art device.

[0080] The absorbent interlabial device 20 can be worn as a “standalone” product. Alternatively, it can be worn as a back up to a tampon,or in combination with a sanitary napkin, pantiliner, or incontinencepad for menstrual or incontinence use. If the absorbent interlabialdevice 20 is used with a sanitary napkin, the sanitary napkin can be ofany thickness. Use with a sanitary napkin may be preferred at night toreduce rear soiling. The interlabial device 20 can be worn inconventional panties, or it can be used with menstrual shorts.

[0081] Numerous alternative embodiments of the absorbent interlabialdevice of the present invention are possible. For example, theseproducts are designed to be removed by urination, although analternative extraction string or loop may be used. These products mayalso be used with medicinal treatments. These products may beconstructed of materials which are biodegradable and/or which willfragment in water with agitation (as in a toilet).

[0082] Preferably, the absorbent interlabial device 20 is flushable. Asused herein the terms “flushable and flushability” refer to a product'sability to pass through typical commercially available household toiletsand plumbing drainage systems without causing clogging or similarproblems that can be directly associated with the physical structure ofthe product. It is recognized, however, that there can be manydifferences between the various types of toilets available. Therefore,for the purposes of the appended claims, a test to determine theflushability of a catamenial product, such as an interlabial device, isset out in the TEST METHODS section of this specification.

[0083] The absorbent interlabial device 20 may also be constructed witha plurality of slits in the main absorbent portion 22 so as to permitbending of the product in multiple independent directions. Such astructure allows the product to more easily respond to the stressesassociated with body movements. As shown in FIG. 12, in preferredversions of any of the embodiments shown in the prior drawing figures,the upper corner portions 26A and the lower corner portions 28A of theinterlabial device 20 may be rounded to reduce the forces that theproduct transfers to the wearer's body when the wearer sits down. Thetop surface of the structure may also have one or more slits or haveother regions of preferred bending so that product may easily adjust tothe vertical pressure against the pelvic floor, to help accommodate thenon-linear surface of the pelvic floor between the clitoris and theperineum.

[0084] The flexible extensions 24 of the absorbent devices above mayalso act as a spring in both wet and dry conditions such that the sidesof the product tend to expand outward pressing against the lateral wallsof the labial vestibule, thereby, holding the product in place. Inaddition, it is preferred that the flexible extensions 24 maintain theability to act as a “spring” when wet, such as when the product issaturated with liquid. Structures, such as polyurethane foams canprovide these properties.

[0085] B. The Emollient Composition.

[0086] The emollient compositions used on the interlabial device of thepresent invention may be solid, liquid, or semisolid at 20° C., i.e. atambient temperatures. Preferably, the emollient compositions have asemisolid consistency that can be described as an unctuous jelly-likeconsistency at 20° C. By “semisolid” is meant that the emollientcomposition has a rheology typical of pseudoplastic or plastic fluids.The term “fluid”, as used herein, means liquid (as opposed to gas).

[0087] The physical states of the emollient composition and thecomponents thereof described herein refer to their states at any timeafter the product is manufactured and the emollient composition isapplied to the product. Thus, for the purpose of the appended claims,the device will be considered to be in the claimed state if it is in thestate specified in storage, on store shelves, or in use. When no shearis applied, the emollient compositions described herein can have theappearance of a semi-solid but can be made to flow as the shear rate isincreased. This is due to the fact that, while the emollient compositioncontains primarily solid components, it also includes some minor liquidcomponents.

[0088] If these emollient compositions are solid or semisolid at ambienttemperatures, they will have a reduced tendency to flow and migrate intothe interior of the absorbent interlabial device to which they areapplied. This also allows less emollient composition to be used forimparting softness and smoothing benefits.

[0089] When an effective amount of the emollient compositions areapplied to the body-contacting surface of the interlabial device 20, theemollient compositions described herein impart a soft, lubricious,smooth feeling to the user of the device. This particular feel has alsobeen characterized as “silky”, “slick”, “smooth”, etc.

[0090] The emollient compositions of the present invention preferablycomprise: (1) an emollient(s); (2) an immobilizing agent(s) for theemollient; (3) optionally a hydrophilic surfactant(s); and (4) otheroptional components.

[0091] 1. Emollient

[0092] The key active ingredient in these emollient compositions is oneor more emollients. As used herein, an emollient is a material thatsmoothes, softens, soothes, supples, coats, lubricates, moisturizes, orcleanses the skin and/or mucous membranes. An emollient typicallyaccomplishes several of these objectives such as soothing, moisturizing,and lubricating the skin. For the purposes of the present invention,these emollients have either a semisolid, a plastic, or a fluidconsistency at 20° C., i.e., at ambient temperatures. By “plasticconsistency” is meant that the emollient behaves as a non-Newtonianliquid which can be made to flow when a sufficient shear rate is appliedthereto. By “fluid consistency” is meant that the emollient behaves as aNewtonian liquid which flows immediately when stressed, with the therate of flow being proportional to the stress. The plastic or fluidemollient consistency allows the emollient composition to impart a soft,lubricious, smoothing feel.

[0093] The emollients will, therefore, preferably have a softening pointat body temperature, 98.6° F. (37° C.). (Body temperature will beslightly less in the area of a female wearer's labial vestibule.)Preferably, the emollient composition has at least one component with apeak heat absorption of less than 99° F. (37° C.). This will ensure thatat least part of the components will melt below body temperature toprovide a more fluid feel and reduced friction against the body. Peakheat absorption can be measured using a differential scanningcalorimeter. In addition, in preferred embodiments, the emollients willsoften over a span of temperatures, rather than having a sharptransition at which it changes from a solid to a liquid. For example,the emollients may begin to soften at about 20° C., or less, and beapproximately 80% melted (“melted”, as used herein, means completelyliquid) at 38° C. (about 100° F.). This will provide the emollientcoated device with a lubricious feel at body temperatures which willincrease as it adjusts from ambient temperature to body temperature.

[0094] The emollients used in the present invention preferably do notcontain any high molecular weight hydrocarbon components. If theemollients used herein contain hydrocarbon components, the molecularweights of such components are preferably less than 1,500, morepreferably less than or equal to about 1,400, and most preferably lessthan or equal to about 1,200. Such emollients will provide more soothingor lotion-like benefits to the wearer's skin than high molecular weightmaterials. They will also be capable of transferring to the wearer'sskin to provide skin care benefits unlike high molecular weightmaterials. In addition, they will remain flexible when the interlabialdevice flexes and bends, and will not tend to flake or chip off theinterlabial device.

[0095] The emollients useful in the present invention are alsosubstantially free of water. Preferably, the overall emollientcomposition is also substantially free of water. By “substantially freeof water” it is meant that water is not intentionally added to theemollient (or emollient composition). Addition of water to the emollient(or emollient composition) is not necessary in preparing or using theemollient compositions on the present invention and could require anadditional drying step. However, minor or trace quantities of water inthe emollient (or emollient composition) that are picked up as a resultof, for example, ambient humidity can be tolerated without adverseeffect. Typically, the emollients (and emollient compositions) used inthe present invention contain about 10% or less water, preferably 5% orless water, more preferably about 1% or less water, and most preferablyabout 0.5% or less water.

[0096] Emollients useful in the present invention can bepetroleum-based, fatty acid ester type, alkyl ethoxylate type, fattyacid ester ethoxylates, fatty alcohol type, polysiloxane, or mixtures ofthese emollients. Suitable petroleum-based emollients include thosehydrocarbons, or mixtures of hydrocarbons, having chain lengths of from16 to 32 carbon atoms. Petroleum based hydrocarbons having these chainlengths include mineral oil (also known as “liquid petrolatum”) andpetrolatum (also known as “mineral wax,” “petroleum jelly” and “mineraljelly”). Mineral oil usually refers to less viscous mixtures ofhydrocarbons having from 16 to 20 carbon atoms. Petrolatum usuallyrefers to more viscous mixtures of hydrocarbons having from 16 to 32carbon atoms. Petrolatum is a particularly preferred emollient foremollient compositions for use on the interlabial device of the presentinvention. Petrolatum has a molecular weight of between about 600 andabout 700.

[0097] Suitable fatty acid ester type emollients include those derivedfrom C₁₂-C₂₈ fatty acids, preferably C₁₆-C₂₂ saturated fatty acids, andshort chain (C₁-C₈, preferably C₁-C₃) monohydric alcohols.Representative examples of such esters include methyl palmitate, methylstearate, isopropyl laurate, isopropyl myristate, butyl myristate, butylstearate, octyl palmitate, isopropyl isostearate, isopropyl palmitate,ethylhexyl palmitate and mixtures thereof Suitable fatty acid esteremollients can also be derived from monoesters and diesters of bothshort chain (C₁ to C₁₀) and longer chain fatty alcohols (C₁₂-C₂₈,preferably C₁₂-C₁₆) and shorter chain organic acids e.g., lactic acid,such as lauryl lactate and cetyl lactate. Additional examples includediisopropyl sebacate, dimethyl sebacate, dioctyl sebacate, dibutylsebacate, diisopropyl adipate, and dicapryl adipate. In addition,mixtures of petroleum based emollients and fatty acid ester emollients,if mixed in the right proportions, can sometimes provide emollientssystems that have a superior feel compared to the pure componentsindividually.

[0098] Suitable alkyl ethoxylate type emollients include C₁₂-C₂₂ fattyalcohol ethoxylates having an average degree of ethoxylation of fromabout 2 to about 30. Preferably, the fatty alcohol ethoxylate emollientis selected from the group consisting of lauryl, cetyl, and stearylethoxylates, and mixtures thereof, having an average degree ofethoxylation ranging from about 2 to about 23. Representative examplesof such alkyl ethoxylates include laureth-3 (a lauryl ethoxylate havingan average degree of ethoxylation of 3), laureth-23 (a lauryl ethoxylatehaving an average degree of ethoxylation of 23), ceteth-10 (a cetylalcohol ethoxylate having an average degree of ethoxylation of 10)steareth-10 (a stearyl alcohol ethoxylate having an average degree ofethoxylation of 10), and ceteareth-10 (a mixture of cetyl and stearylethoxylates having an average degree of ethoxylation of 10). These alkylethoxylate emollients are typically used in combination with thepetroleum-based emollients, such as petrolatum, at a weight ratio ofalkyl ethoxylate emollient to petroleum-based emollient of from about1:1 to about 1:5, preferably from about 1:2 to about 1:4.

[0099] Suitable fatty alcohol type emollients include C₁₂-C₂₂ fattyalcohols, preferably C₁₆-C₁₈ fatty alcohols. Representative examplesinclude cetyl alcohol and stearyl alcohol, and mixtures thereof Thesefatty alcohol emollients are typically used in combination with thepetroleum-based emollients, such as petrolatum, at a weight ratio offatty alcohol emollient to petroleum-based emollient of from about 1:1to about 1:5, preferably from about 1:1 to about 1:2.

[0100] Other suitable types of emollients for use in the presentinvention include polysiloxane compounds. In general suitablepolysiloxane materials for use in the present invention include thosehaving monomeric siloxane units of the following structure:

[0101] wherein, R₁ and R₂, for each independent siloxane monomeric unitcan each independently be hydrogen or any alkyl, aryl, alkenyl, alkaryl,arakyl, cycloalkyl, halogenated hydrocarbon, or other radical. Any ofsuch radicals can be substituted or unsubstituted. R₁ and R₂ radicals ofany particular monomeric unit may differ from the correspondingfunctionalities of the next adjoining monomeric unit. Additionally, thepolysiloxane can be either a straight chain, a branched chain or have acyclic structure. The radicals R₁ and R₂ can additionally independentlybe other silaceous functionalities such as, but not limited tosiloxanes, polysiloxanes, silanes, and polysilanes. The radicals R₁ andR₂ may contain any of a variety of organic functionalities including,for example, alcohol, carboxylic acid, phenyl, and aminefunctionalities.

[0102] Exemplary alkyl radicals are methyl, ethyl, propyl, butyl,pentyl, hexyl, octyl, decyl, octadecyl, and the like. Exemplary alkenylradicals are vinyl, allyl, and the like. Exemplary aryl radicals arephenyl, diphenyl, naphthyl, and the like. Exemplary alkaryl radicals aretoyl, xylyl, ethylphenyl, and the like. Exemplary aralkyl radicals arebenzyl, alpha-phenylethyl, beta-phenylethyl, alpha-phenylbutyl, and thelike. Exemplary cycloalkyl radicals are cyclobutyl, cyclopentyl,cyclohexyl, and the like. Exemplary halogenated hydrocarbon radicals arechloromethyl, bromoethyl, tetrafluorethyl, fluorethyl, trifluorethyl,trifluorotloyl, hexafluoroxylyl, and the like.

[0103] Viscosity of useful polysiloxanes useful may vary as widely asthe viscosity of polysiloxanes in general vary, so long as thepolysiloxane is flowable or can be made to be flowable for applicationto the body-contacting surface of the interlabial device. This includes,but is not limited to, viscosity as low as 5 centistokes (at 37° C. asmeasured by a glass viscometer) to about 20,000,000 centistokes.Preferably the polysiloxanes have a viscosity at 37° C. ranging fromabout 5 to about 5,000 centistokes, more preferably from about 5 toabout 2,000 centistokes, most preferably from about 100 to about 1000centistokes. High viscosity polysiloxanes which themselves are resistantto flowing can be effectively deposited upon the body-contacting surfaceby such methods as, for example, emulsifying the polysiloxane insurfactant or providing the polysiloxane in solution with the aid of asolvent, such as hexane, listed for exemplary purposes only. Particularmethods for applying polysiloxane emollients to body-contacting surfaceare discussed in more detail hereinafter.

[0104] Preferred polysiloxanes compounds for use in the presentinvention are disclosed in U.S. Pat. No. 5,059,282 (Ampulski, et al),issued Oct. 22, 1991, which is incorporated herein by reference.Particularly preferred polysiloxane compounds for use as emollients inthe emollient compositions include phenyl-functional polymethylsiloxanecompounds (e.g., Dow Corning 556 Cosmetic-Grade Fluid:polyphenylmethylsiloxane) and cetyl or stearyl functionalizeddimethicones such as Dow 2502 and Dow 2503 polysiloxane fluids,respectively. In addition to such substitution with phenyl-functional oralkyl groups, effective substitution may be made with amino, carboxyl,hydroxyl, ether, polyether, aldehyde, ketone, amide, ester, and thiolgroups. Of these effective substituent groups, the family of groupscomprising phenyl, amino, alkyl, carboxyl, and hydroxyl groups are morepreferred than the others; and phenyl-functional groups are mostpreferred.

[0105] Preferably, emollient compositions containing a polysiloxane willfurther comprise a petroleum based emollient selected from the groupconsisting of mineral oil, petrolatum, and mixtures thereof. However,the polysiloxanes emollients described above can also be used alone.

[0106] Besides petroleum-based emollients, fatty acid ester emollients,fatty acid ester ethoxylates, alkyl ethoxylate emollients and fattyalcohol emollients, the emollients useful in the present invention caninclude minor amounts (e.g., up to about 10% of the total emollient) ofother, conventional emollients/solvents. These other, conventionalemollients/solvents include propylene glycol, polyethylene glycol,hexylene glycol, glycerine, triethylene glycol, spermaceti or otherwaxes, fatty acids, and fatty alcohol ethers having from 12 to 28 carbonatoms in their fatty chain, such as stearic acid, propoxylated fattyalcohols; glycerides, acetoglycerides, and ethoxylated glycerides ofC₁₂-C₂₈ fatty acids; other fatty esters of polyhydroxy alcohols; lanolinand its derivatives; silicone polyether copolymers, and polysiloxaneshaving a viscosity at 20° C. of from about 5 to about 2,000 centistokessuch as disclosed in U.S. Pat. No. 5,059,282 (Ampulski et al), issuedOct. 22, 1991, which is incorporated by reference. These otheremollients should be included in a manner such that the solid orsemisolid characteristics of the emollient composition are maintained.

[0107] The amount of emollient that can be included in the emollientcomposition will depend on a variety of factors, including theparticular emollient involved, the emollient-like benefits desired, theother components in the emollient composition and like factors. Theemollient composition can comprise from about 5 to about 95% of theemollient. Preferably, the emollient composition comprises from about 10to about 90% by weight, more preferably from 20 to about 80%, mostpreferably from about 40 to about 75%, of the emollient.

[0108] 2. Immobilizing Agent

[0109] An optional component of the emollient compositions useful on theinterlabial device of present invention is an agent capable ofimmobilizing the emollient on the surface of the body-contacting surface20A of the device. Because the emollient in the composition has aplastic or fluid consistency at 20° C., it tends to flow or migrate,even when subjected to modest shear. When applied to an absorbentinterlabial device, especially in a melted or molten state, theemollient will not remain primarily on the body-contacting surface ofthe device. Instead, the emollient will tend to migrate and flow intothe interior of the device.

[0110] The need for an immobilizing agent is generally greater of thebody-contacting surface of the interlabial device comprises an absorbentmaterial, such as cellulose, than it is if the body-contacting surfacecomprises an apertured plastic film since the apertured film will nottend to absorb the emollient. The immobilizing agent counteracts thetendency of the emollient to migrate or flow by keeping the emollientprimarily localized on the body-contacting surface of the absorbentinterlabial device. This is believed to be due, in part, to the factthat the immobilizing agent forms hydrogen bonds with any cellulose inthe interlabial device. Through this hydrogen bonding, the immobilizingagent becomes localized on the surface of the interlabial device. Sincethe immobilizing agent is also miscible with the emollient (orsolubilized in the emollient with the aid of an appropriate emulsifier),it entraps the emollient on the surface of the absorbent device as well.

[0111] It is also advantageous to “lock” the immobilizing agent on thebody-contacting surface of the interlabial device. This can beaccomplished by using immobilizing agents which quickly solidify (e.g.,crystallize) at the surface of the interlabial device. Alternatively,outside cooling of the treated interlabial device by the flow of airover the surface of the device when the device is moving rapidly betweenstations on a manufacturing line may speed up crystallization of theimmobilizing agent. In addition, outside cooling of the treatedinterlabial device via blowers, fans, etc. can speed up crystallizationof the immobilizing agent.

[0112] In addition to being miscible with (or solubilized in) theemollient, the immobilizing agent preferably has a melting point of atleast about 35° C. This is so the immobilizing agent itself will nothave a tendency to migrate or flow. Preferred immobilizing agents willhave melting points of at least about 40° C. Typically, the immobilizingagent will have a melting point in the range of from about 50° to about150° C.

[0113] The viscosity of the immobilizing agent should also be as high aspossible to keep the emollient from flowing into the interior of theinterlabial device. Unfortunately, high viscosities can also lead toemollient compositions that are difficult to apply without processingproblems. Therefore, a balance must be achieved so the viscosities arehigh enough to keep the immobilizing agent localized on the surface ofthe interlabial device, but not so high as to cause processing problems.Suitable viscosities for the immobilizing agent will typically rangefrom about 5 to about 200 centipoises, preferably from about 15 to about100 centipoises, measured at 60° C.

[0114] Suitable immobilizing agents for the present invention cancomprise a member selected from the group consisting of C₁₄-C₂₂ fattyalcohols, C₁₂-C₂₂ fatty acids, and C₁₂-C₂₂ fatty alcohol ethoxylateshaving an average degree of ethoxylation ranging from 2 to about 30, andmixtures thereof Preferred immobilizing agents include C₁₆-C₁₈ fattyalcohols, most preferably selected from the group consisting of cetylalcohol, stearyl alcohol, and mixtures thereof. Mixtures of cetylalcohol and stearyl alcohol are particularly preferred. Other preferredimmobilizing agents include C₁₆-C₁₈ fatty acids, most preferablyselected from the group consisting of cetyl acid, stearyl acid, andmixtures thereof Mixtures of cetyl acid and stearyl acid areparticularly preferred. Still other preferred immobilizing agentsinclude C₁₆-C₁₈ fatty alcohol ethoxylates having an average degree ofethoxylation ranging from about 5 to about 20. Preferably, the fattyalcohols, fatty acids and fatty alcohols are linear.

[0115] Importantly, these preferred immobilizing agents such as theC₁₆-C₁₈ fatty alcohols increase the rate of crystallization of theemollient causing the emollient to crystallize rapidly onto the surfaceof the interlabial device. Lower emollient levels can therefore beutilized or a superior feel can be delivered.

[0116] Optionally, other types of immobilizing agents can be used incombination with the fatty alcohols, fatty acids, and fatty alcoholethoxylates described above. Typically, only minor amounts of theseother types of immobilizing agents would be used (i.e., up to about 10%of the total immobilizing agent). Examples of these other types ofimmobilizing agents includes polyhydroxy fatty acid esters, polyhydroxyfatty acid amides, waxes (preferably waxes having a molecular weight ofless than 1,500, more preferably less than or equal to 1,400, and mostpreferably less than or equal to about 1,200), and mixtures thereof Tobe useful as immobilizing agents, the polyhydroxy moiety of the ester oramide should have at least one free hydroxy group. It is believed thatthese free hydroxy group(s) are the ones that co-crosslink throughhydrogen bonds with any cellulosic fibers of the interlabial device towhich the emollient composition is applied and homo-crosslink, alsothrough hydrogen bonds, the hydroxy groups of the alcohol, acid, esteror amide, thus entrapping and immobilizing the other components in theemollient matrix. Suitable waxes include, but are not limited tomicrocrystalline waxes, synthetic waxes, such as polyethylene-typewaxes, and silicone waxes.

[0117] It is also believed that molecules such as long chain fattyalcohols can orient themselves and interact with one another to form alamellar structure. In this lamellar structure, the hydroxyl groups andalkyl chains of neighboring alcohol molecules orient and interact withone another to form an organized structure. In this “packingarrangement,” the hydroxyl groups of the alcohols form hydrogen bondswith the cellulose polar functionalities (e.g., hydroxy or carbonyl) to“immobilize” the alcohols at the body-contacting surface of theinterlabial device. Since the alcohols are miscible with the preferredemollients, anchoring and/or immobilization of the emollient will occur.

[0118] Preferred esters and amides will have three or more free hydroxygroups on the polyhydroxy moiety and are typically nonionic incharacter. Because of the possible skin sensitivity of those usinginterlabial devices to which the emollient composition is applied, theseesters and amides should also be relatively mild and non-irritating tothe skin.

[0119] Suitable polyhydroxy fatty acid esters for use in the presentinvention will have the formula:

[0120] wherein R is a C₅-C₃₁ hydrocarbyl group, preferably straightchain C₇-C₁₉ alkyl or alkenyl, more preferably straight chain C₉-C₁₇alkyl or alkenyl, most preferably straight chain C₁₁-C₁₇ alkyl oralkenyl, or mixture thereof; Y is a polyhydroxyhydrocarbyl moiety havinga hydrocarbyl chain with at least 2 free hydroxyls directly connected tothe chain; and n is at least 1. Suitable Y groups can be derived frompolyols such as glycerol, pentaerythritol; sugars such as raffinose,maltodextrose, galactose, sucrose, glucose, xylose, fructose, maltose,lactose, mannose and erythrose; sugar alcohols such as erythritol,xylitol, malitol, mannitol and sorbitol; and anhydrides of sugaralcohols such as sorbitan.

[0121] One class of suitable polyhydroxy fatty acid esters for use inthe present invention comprises certain sorbitan esters, preferably thesorbitan esters of C₁₆-C₂₂ saturated fatty acids. Because of the mannerin which they are typically manufactured, these sorbitan esters usuallycomprise mixtures of mono-, di-, tri-, etc. esters. Representativeexamples of suitable sorbitan esters include sorbitan palmitates (e.g.,SPAN 40), sorbitan stearates (e.g., SPAN 60), and sorbitan behenates,that comprise one or more of the mono-, di- and tri-ester versions ofthese sorbitan esters, e.g., sorbitan mono-, di- and tri-palmitate,sorbitan mono-, di- and tri-stearate, sorbitan mono-, di andtri-behenate, as well as mixed tallow fatty acid sorbitan mono-, di- andtri-esters. Mixtures of different sorbitan esters can also be used, suchas sorbitan palmitates with sorbitan stearates. Particularly preferredsorbitan esters are the sorbitan stearates, typically as a mixture ofmono-, di- and tri-esters (plus some tetraester) such as SPAN 60, andsorbitan stearates sold under the trade name GLYCOMUL-S by Lonza, Inc.Although these sorbitan esters typically contain mixtures of mono-, di-and tri-esters, plus some tetraester, the mono- and di-esters areusually the predominant species in these mixtures.

[0122] Another class of suitable polyhydroxy fatty acid esters for usein the present invention comprises certain glyceryl monoesters,preferably glyceryl monoesters of C₁₆-C₂₂ saturated fatty acids such asglyceryl monostearate, glyceryl monopalmitate, and glycerylmonobehenate. Again, like the sorbitan esters, glyceryl monoestermixtures will typically contain some di- and triester. However, suchmixtures should contain predominantly the glyceryl monoester species tobe useful in the present invention.

[0123] Another class of suitable polyhydroxy fatty acid esters for usein the present invention comprise certain sucrose fatty acid esters,preferably the C₁₂-C₂₂ saturated fatty acid esters of sucrose. Sucrosemonoesters are particularly preferred and include sucrose monostearateand sucrose monolaurate.

[0124] Suitable polyhydroxy fatty acid amides for use in the presentinvention will have the formula:

[0125] wherein R¹ is H, C₁-C₄ hydrocarbyl, 2-hydroxyethyl,2-hydroxypropyl, methoxyethyl, methoxypropyl or a mixture thereof,preferably C₁-C₄ alkyl, methoxyethyl or methoxypropyl, more preferablyC₁ or C₂ alkyl or methoxypropyl, most preferably C₁ alkyl (i.e., methyl)or methoxypropyl; and R² is a C₅-C₃₁ hydrocarbyl group, preferablystraight chain C₇-C₁₉ alkyl or alkenyl, more preferably straight chainC₉-C₁₇ alkyl or alkenyl, most preferably straight chain C₁₁ -C₁₇ alkylor alkenyl, or mixture thereof; and Z is a polyhydroxyhydrocarbyl moietyhaving a linear hydrocarbyl chain with at least 3 hydroxyls directlyconnected to the chain. See U.S. Pat. No. 5,174,927 (Honsa), issued Dec.29, 1992 (herein incorporated by reference) which discloses thesepolyhydroxy fatty acid amides, as well as their preparation.

[0126] The Z moiety preferably will be derived from a reducing sugar ina reductive amination reaction; most preferably glycityl. Suitablereducing sugars include glucose, fructose, maltose, lactose, galactose,mannose, and xylose. High dextrose corn syrup, high fructose corn syrup,and high maltose corn syrup can be utilized, as well as the individualsugars listed above. These corn syrups can yield mixtures of sugarcomponents for the Z moiety.

[0127] The Z moiety preferably will be selected from the groupconsisting of —CH₂—(CHOH)_(n)—CH₂OH, —CH(CHOH)—[(CHOH)_(n-1)]—CH₂OH,—CHOH-CH₂—(CHOH)₂(CHOR³)(CHOH)—CH₂OH, where n is an integer from 3 to 5,and R³ is H or a cyclic or aliphatic monosaccharide. Most preferred arethe glycityls where n is 4, particularly —CH₂—(CHOH)₄—CH₂OH.

[0128] In the above formula, R¹ can be, for example, N-methyl, N-ethyl,N-propyl, N-isopropyl, N-butyl, N-2-hydroxyethyl, N-methoxypropyl orN-2-hydroxypropyl,. R² can be selected to provide, for example,cocamides, stearamides, oleamides, lauramides, myristamides,capricamides, palmitamides, tallowamides, etc. The Z moiety can be1-deoxyglucityl, 2-deoxyfructityl, 1-deoxymaltityl, 1-deoxylactityl,1-deoxygalactityl, 1-deoxymannityl, 1-deoxymaltotriotityl, etc.

[0129] The most preferred polyhydroxy fatty acid amides have the generalformula:

[0130] wherein R¹ is methyl or methoxypropyl; R² is a C₁₁-C₁₇straight-chain alkyl or alkenyl group. These include N-lauryl-N-methylglucamide, N-lauryl-N-methoxypropyl glucamide, N-cocoyl-N-methylglucamide, N-cocoyl-N-methoxypropyl glucamide,N-palmityl-N-methoxypropyl glucamide, N-tallowyl-N-methyl glucamide, orN-tallowyl-N-methoxypropyl glucamide.

[0131] As previously noted, some of the immobilizing agents require anemulsifier for solubilization in the emollient. This is particularly thecase for certain of the glucamides such as the N-alkyl-N-methoxypropylglucamides having HLB values of at least about 7. Suitable emulsifierswill typically include those having HLB values below about 7. In thisregard, the sorbitan esters previously described, such as the sorbitanstearates, having HLB values of about 4.9 or less have been found usefulin solubilizing these glucamide immobilizing agents in petrolatum. Othersuitable emulsifiers include steareth-2 (polyethylene glycol ethers ofstearyl alcohol that conform to the formula CH₃(CH₂)₁₇(OCH₂CH₂)_(n)OH,where n has an average value of 2), sorbitan tristearate, isosorbidelaurate, and glyceryl monostearate. The emulsifier can be included in anamount sufficient to solubilize the immobilizing agent in the emollientsuch that a substantially homogeneous mixture is obtained. For example,an approximately 1:1 mixture of N-cocoyl-N-methyl glucamide andpetrolatum that will normally not melt into a single phase mixture, willmelt into a single phase mixture upon the addition of 20% of a 1:1mixture of steareth-2 and sorbitan tristearate as the emulsifier.

[0132] The amount of immobilizing agent that should be included in theemollient composition will depend on a variety of factors, including theparticular emollient involved, the particular immobilizing agentinvolved, whether an emulsifier is required to solubilize theimmobilizing agent in the emollient, the other components in theemollient composition and like factors. The emollient composition cancomprise from about 5 to about 80% of the immobilizing agent.Preferably, the emollient composition comprises from about 5 to about50%, most preferably from about 10 to about 40%, of the immobilizingagent.

[0133] 3. Optional Hydrophilic Surfactant

[0134] The interlabial device of the present invention is preferablydisposed of by flushing the same down a conventional toilet. In suchcases, it may be desirable that the interlabial device be sufficientlywettable so that it will not float. Depending upon the particularimmobilizing agent used in the emollient composition, an additionalhydrophilic surfactant (or a mixture of hydrophilic surfactants) may, ormay not, be required to improve wettability. For example, someimmobilizing agents, such as N-cocoyl-N-methoxypropyl glucamide have HLBvalues of at least about 7 and are sufficiently wettable without theaddition of hydrophilic surfactant. Other immobilizing agents such asthe C₁₆-C₁₈ fatty alcohols having BLB values below about 7 may requireaddition of hydrophilic surfactant to improve wettability. Similarly, ahydrophobic emollient such as petrolatum may require the addition of ahydrophilic surfactant.

[0135] Suitable hydrophilic surfactants are preferably miscible with theemollient and the immobilizing agent so as to form homogeneous mixtures.Because of possible skin sensitivity of those using the interlabialdevice, these surfactants should also be relatively mild andnon-irritating to the skin. Typically, these hydrophilic surfactants arenonionic to be non-irritating to the skin.

[0136] Suitable nonionic surfactants are preferably substantiallynonmigratory after the emollient composition is applied to theinterlabial device and will typically have HLB values in the range offrom about 4 to about 20, preferably from about 7 to about 20. To benonmigratory, these nonionic surfactants will typically have melttemperatures greater than the temperatures commonly encountered duringstorage, shipping, merchandising, and use of absorbent articles, e.g.,at least about 30° C. In this regard, these nonionic surfactants willpreferably have melting points similar to those of the immobilizingagents previously described.

[0137] Suitable nonionic surfactants for use in emollient compositionsinclude alkylglycosides; alkylglycoside ethers as described in U.S. pat.No. 4,011,389 (Langdon, et al), issued Mar. 8, 1977;alkylpolyethoxylated esters such as Pegosperse 1000MS (available fromLonza, Inc., Fair Lawn, N.J.), ethoxylated sorbitan mono-, di- and/ortri-esters of C₁₂-C₁₈ fatty acids having an average degree ofethoxylation of from about 2 to about 20, preferably from about 2 toabout 10, such as TWEEN 60 (sorbitan esters of stearic acid having anaverage degree of ethoxylation of about 20) and TWEEN 61 (sorbitanesters of stearic acid having an average degree of ethoxylation of about4), and the condensation products of aliphatic alcohols with from about1 to about 54 moles of ethylene oxide. The alkyl chain of the aliphaticalcohol is typically in a straight chain (linear) configuration andcontains from about 8 to about 22 carbon atoms. Particularly preferredare the condensation products of alcohols having an alkyl groupcontaining from about 11 to about 22 carbon atoms with from about 2 toabout 30 moles of ethylene oxide per mole of alcohol. Examples of suchethoxylated alcohols include the condensation products of myristylalcohol with 7 moles of ethylene oxide per mole of alcohol, thecondensation products of coconut alcohol (a mixture of fatty alcoholshaving alkyl chains varying in length from 10 to 14 carbon atoms) withabout 6 moles of ethylene oxide. A number of suitable ethoxylatedalcohols are commercially available, including TERGITOL 15-S-9 (thecondensation product of C₁₁-C₁₅ linear alcohols with 9 moles of ethyleneoxide), marketed by Union Carbide Corporation; KYRO EOB (condensationproduct of C₁₃-C₁₅ linear alcohols with 9 moles of ethylene oxide),marketed by The Procter & Gamble Co., the NEODOL brand name surfactantsmarketed by Shell Chemical Co., in particular NEODOL 25-12 (condensationproduct of C₁₂-C₁₅ linear alcohols with 12 moles of ethylene oxide) andNEODOL 23-6.5T (condensation product of C₁₂-C₁₃ linear alcohols with 6.5moles of ethylene oxide that has been distilled (topped) to removecertain impurities), and especially the PLURAFAC brand name surfactantsmarketed by BASF Corp., in particular PLURAFAC A-38 (a condensationproduct of a C₁₈ straight chain alcohol with 27 moles of ethyleneoxide). (Certain of the hydrophilic surfactants, in particularethoxylated alcohols such as NEODOL 25-12, can also function as alkylethoxylate emollients). Other examples of preferred ethoxylated alcoholsurfactants include ICI's class of Brij surfactants and mixturesthereof, with Brij 76 ( i.e., Steareth-10) and Brij 56 (i.e., Cetyl-10)being especially preferred. Also, mixtures of cetyl alcohol and stearylalcohol ethoxylated to an average degree of ethoxylation of from about10 to about 20 may also be used as the hydrophilic surfactant.

[0138] Another type of suitable surfactant for use in the presentinvention includes Aerosol OT, a dioctyl ester of sodium sulfosuccinicacid marketed by American Cyanamid Company.

[0139] Still another type of suitable surfactant for use in the presentinvention includes silicone copolymers such as General Electric SF 1188(a copolymer of a polydimethylsiloxane and a polyoxyalkylene ether) andGeneral Electric SF 1228 (a silicone polyether copolymer). Thesesilicone surfactants can be used in combination with the other types ofhydrophilic surfactants discussed above, such as the ethoxylatedalcohols. These silicone surfactants have been found to be effective atconcentrations as low as 0.1%, more preferably from about 0.25 to about1.0%, by weight of the emollient composition.

[0140] The amount of hydrophilic surfactant required to increase thewettability of the emollient composition to a desired level will dependupon the HLB value and level of immobilizing agent used, the HLB valueof the surfactant used and like factors. The emollient composition cancomprise from about 1 to about 50% of the hydrophilic surfactant whenneeded to increase the wettability properties of the composition.Preferably, the emollient composition comprises from about 1 to about25%, most preferably from about 10 to about 20%, of the hydrophilicsurfactant when needed to increase wettability.

[0141] It is also possible that a surfactant can be used which isseparately applied to the interlabial device, and is not included in theemollient composition. If a surfactant is separately applied to theinterlabial device, it is preferably applied to the back surface 20B ofthe same so that it does not come in contact with the wearer's body. Inother embodiments, particularly where the interlabial device is notprovided with a liquid impervious backsheet, the surfactant could beeliminated altogether. In such cases, the interlabial device will besufficiently wettable that it is flushable. The back surface of such aninterlabial device will typically not have an emollient coating thereon,and will readily wet and sink when placed in a toilet.

[0142] 4. Other Optional Components

[0143] Emollient compositions can comprise other optional componentstypically present in emollient, creams, and emollients of this type.These optional components include water, viscosity modifiers, pHmodifiers, buffers, perfumes, disinfectant antibacterial actives,pharmaceutical actives, film formers, deodorants, opacifiers,astringents, solvents, organic acids, preservatives, anti-viral actives,drugs, vitamins, aloe vera, panthenol, and the like. In addition,stabilizers can be added to enhance the shelf life of the emollientcomposition such as cellulose derivatives, proteins and lecithin. All ofthese materials are well known in the art as additives for suchformulations and can be employed in appropriate amounts in the emollientcompositions for use in the present invention.

[0144] C. Treating the Interlabial Structure With Emollient Composition.

[0145] The body-contacting surface of the interlabial device 20 ispre-treated. The body-contacting surface 20A is treated with a substanceor an emollient (such as a liquid) which is suitable for contact withthe wearer's skin and which will help or aid in maintaining thehydration level of the labial tissue and reduce friction therewith.

[0146] In preparing lotioned interlabial products of the presentinvention, the emollient composition is applied to the body-contactingsurface 20A of the interlabial product. Any of a variety of applicationmethods that evenly distribute lubricious materials having a molten orliquid consistency can be used. Suitable methods include spraying,printing (e.g., flexographic printing), coating (e.g., gravure coating),extrusion, or combinations of these application techniques, e.g.spraying the emollient composition on a rotating surface, such as acalender roll, that then transfers the composition to thebody-contacting surface of the interlabial device 20.

[0147] The manner of applying the emollient composition to theinterlabial device should be such that the body-contacting surface 20Adoes not become saturated with the emollient composition. If thebody-contacting surface 20A becomes saturated with the emollientcomposition, there is a greater potential for the emollient to block thepores or other openings in the body-contacting surface, reducing theability to transmit fluid through the body-contacting surface to theabsorbent portions of the interlabial device. Also, saturation of thebody-contacting surface 20A is not required to obtain the benefitsdescribed herein.

[0148] The emollient composition is preferably applied to thebody-contacting surface 20A of the interlabial device in an amountranging from about 0.1 mg/cm² to about 30 mg/cm² more preferably fromabout 1 mg/cm² to about 15 mg/cm² (mg of emollient per square centimeterof coated body-contacting surface). Because the emollient issubstantially immobilized on the surface of the body-contacting surface,less emollient composition is needed to impart the desired benefits.Such relatively low levels of emollient composition are adequate toimpart the desired benefits to the interlabial device, yet do notsaturate the interlabial device's absorbency and/or wettabilityproperties.

[0149] The emollient composition may be applied to the entirebody-contacting surface of the interlabial device, or portions thereofFor example, the emollient composition may be applied to thebody-contacting portion of the main absorbent portion, to thebody-contacting portion of the flexible extensions, or to thebody-contacting portion of both the main absorbent portion and theflexible extensions. Preferably, the emollient composition is applied tothe body-contacting portion of both the main absorbent portion and anyflexible extensions.

[0150] The emollient composition can also be applied nonuniformly to thebody-contacting surface of the interlabial device. By “nonuniform” ismeant that the amount, pattern of distribution, etc. of the emollientcomposition can vary over the body-contacting surface. For example, someportions of the body-contacting surface can have greater or lesseramounts of emollient composition, including portions of the surface thatdo not have any emollient composition on it. If the emollient is appliednonuniformly, the levels of the emollient specified above are preferablyaverages of the amount of coating applied to the entire surface.

[0151] The emollient composition can be applied to the interlabialdevice at any point during assembly. For example, the emollientcomposition can be applied to the body-contacting surface of thefinished interlabial device before it has been packaged. The emollientcomposition can also be applied to components of the interlabial devicebefore they are combined with the other raw materials to form thefinished interlabial device.

[0152] The emollient composition may be applied from a melt thereof tothe body-contacting surface of the interlabial device. If the emollientcomposition melts at a temperature above ambient temperatures, it can beapplied as a heated coating to the body-contacting surface. Typically,the emollient composition is heated to a temperature in the range fromabout 35° to about 100° C., preferably from 40° to about 90° C., priorto being applied to the body-contacting surface of the interlabialdevice. Once the melted emollient composition has been applied to thebody-contacting surface of the interlabial device, it is allowed to cooland solidify to form solidified coating or film on the body-contactingsurface. Preferably, the application process is designed to aid in thecooling/set up of the emollient.

[0153] In applying the emollient composition to interlabial devices,spraying, gravure coating and extrusion coating methods are preferred.One preferred method, when the interlabial device is provided with atopsheet, is spraying the emollient on the topsheet before the topsheetis assembled with the other raw materials into the finished product. Incarrying out this method, a web of topsheet material is unwound fromparent topsheet roll and advanced to a spray station where one side ofthe web is sprayed with a hot, molten (e.g., 65° C.) emollientcomposition. After leaving spray station, the web of topsheet materialbecomes an emollient-treated topsheet which is thereafter used in theassembly of the finished product.

[0154] An alternative preferred method involves continuous orintermittent spraying of the emollient composition on thebody-contacting surface of the assembled or partially assembledinterlabial device. When it is said that the emollient composition canbe applied to a partially assembled interlabial device, there are anumber of ways this can be accomplished. These include, but are notlimited to the following. If the interlabial device is provided withflexible extensions, the web of material that is converted into theflexible extensions can be treated before the material is joined to themain absorbent portion to form the interlabial device. The mainabsorbent portion could similarly be treated separately before theflexible extensions are joined thereto. In this regard, it iscontemplated that the main absorbent portion will initially be in theform of a continuous rope-like web that will be intermittently cut intodiscrete lengths to form a plurality of main absorbent portions. It willoften be most convenient to treat the main absorbent portion before itis cut into discrete lengths.

[0155] In treating the interlabial device by spraying the emollient ontothe assembled or partially assembled device, the interlabial device ordesired portion or component thereof can be carried in any suitablemanner to a spray station where the body-contacting surface of theinterlabial device is sprayed with a hot, molten (e.g., 65° C.)emollient composition. After leaving the spray station, the interlabialdevice has an emollient coated body-contacting surface. The amount ofemollient composition transferred to body-contacting surface can becontrolled by: (1) the rate at which the molten emollient composition issprayed from spray station; and/or (2) the speed at which theinterlabial device travels under the spray station.

[0156] Providing the interlabial device with a coating of emollientprovides a number of advantages. The emollient-treated absorbent deviceprovides a reduction in frictional discomfort associated with rubbing ofthe device against the labial walls and sticking of the surfaces of thedevice to the labial walls. The interlabial device also has less of adrying sensation to the inside surfaces of the wearer's labia due to thepresence of the emollient. In addition, as shown by comparing FIGS. 11and 12, the interlabial device can be inserted into the space betweenthe wearer's labia with less friction so that it will more easily befully inserted into the desired wearing position.

[0157]FIG. 11 shows a hypothetical example of a prior art interlabialdevice that is not treated with an emollient. FIG. 11 shows a prior artinterlabial pad in place in a wearer's body. When the user attempts toinsert such the device, the friction between the body-contacting surfaceof the device and the inside walls of the wearer's labia may prevent thedevice from being fully inserted as shown in FIG. 11. This may preventthe device from providing maximum protection against leakage. It mayalso result in portions of the lower portion of the device, such aslower corner portions 28A, remaining outside the labial vestibule. Whenthe wearer sits, these lower corner portions 28A may be pressed upwardcausing discomfort to the wearer.

[0158]FIG. 12 shows how, on the other hand, the emollient-treatedinterlabial device of the present invention will tend to be capable ofbeing more fully inserted into the labial vestibule so that the lowercorner portions reside completely inside the wearer's labial vestibule.

[0159] Another advantage of the interlabial device of the presentinvention is that the emollients described herein are substantially freeof water. Hydrous emollients are less preferred because such materialscan support bacterial growth during storage of the product prior toshipment to the consumer.

[0160] In other embodiments, the emollients described herein could beapplied to other types of absorbent articles, particularly other typesof feminine hygiene articles, such as sanitary napkins, panty liners,incontinence devices, and tampons. The relatively lower molecular weightand melting temperature of the emollients described herein make themparticularly suitable for use with absorbent articles that have anapertured film topsheet such as those topsheet materials describedabove. Without wishing to be bound to any particular theory this isbelieved to be so because such topsheets will not have fibers which helpmaintain the coating thereon by the emollient embedding into the spacesbetween the same. Higher molecular weight and higher melting pointtemperature materials will typically readily flake off apertured films,when such films are flexed.

[0161] The disclosure of all patents, patent applications (and anypatents which issue thereon, as well as any corresponding publishedforeign patent applications), and publications mentioned throughout thisdescription are hereby incorporated by reference herein. It is expresslynot admitted, however, that any of the documents incorporated byreference herein teach or disclose the present invention.

Test Methods Absorbent Capacity

[0162] Absorbent capacity may be determined as follows. The test isperformed on samples that have been conditioned by leaving them in aroom at 50% relative humidity and at 73° F. for a period of two hoursprior to the test. The test should be performed under similarconditions.

[0163] The article is weighed to the nearest 0.1 gram. The article isthen submerged in a beaker of sterile 0.9% saline solution (obtainablefrom the Baxter Travenol Company of Deerfield, Ill.), such that thearticle is totally submerged and is not bent or otherwise twisted orfolded. The article is submerged for 10 minutes. The article is removedfrom the saline and laid horizontally on a wire mesh screen havingsquare openings 0.25 inches by 0.25 inches (0.64 cm by 0.64 cm) for fiveminutes to allow the saline to drain out to the article. Both sides ofthe article are then covered with absorbent blotters, such as the filterpaper #631 available from the Filtration Science Corp., Eaton-DikemanDivision of Mount Holly Springs, Pa. A uniform 17.6 grams per squarecentimeter load is placed over the article to squeeze excess fluid out.The absorbent blotters are replaced every 30 seconds until the amount offluid transferred to the absorbent blotters is less than 0.5 grams in a30 second period. Next, the article is weighed to the nearest 0.1 gramand the dry weight of the article is subtracted. The difference in gramsis the absorbent capacity of the article.

Three Point Bend Test

[0164] The Three Point Bend Test is performed on samples that have beenconditioned by leaving them in a room at 50% relative humidity and at73° F. for a period of two hours prior to the test. The test should beperformed under similar conditions.

[0165] The three point bend test uses an INSTRON Model 4502 tensile andcompression testing machine, which is available from Instron Corporationof Canton, Mass. The test also uses a special displacement “T-rod” and aspecial test sample holder. As shown in FIG. 13, the “T-rod” 1101comprises a pair of 6.40 mm diameter metal rods perpendicularly mountedtogether. The drive rod 1102 is about 125 mm long and the push rod 1103is about 75 mm long. Preferably, the end of the drive rod 1102 istapered to fit the circumference of the push rod 1103 and the two areglued, welded and/or screwed to each other. The opposite end of thedrive rod 1102 is mounted to the crosshead unit of the INSTRON machine.The test sample holder 1104 comprises a fixture base 1105 forpositioning and supporting a pair of supporting rods 1108. The fixturebase 1105 comprises a base 1105 and two rectangular supports 1107mounted in parallel on the base 1106. The base 1106 and the supports1107 are each preferably made of LEXAN (plexiglas) plate of about 10 mmto about 13 mm thickness. A supporting rod 1108 of the same materials asthe “T-bar” and about 150 mm long is mounted on each support 1107 of thefixture base 1105. The supporting rods 1108 are mounted so as to leave10 mm of open space between them (measured at the point on each rodwhich is closest to the other). As shown in FIG. 13, the “T-rod” 1101 iscentered between the supporting rods 1108.

[0166] The INSTRON machine is set for a crosshead speed of 2.0 in/min(50.8 mm/min). The INSTRON machine is set up so that the crosshead unitwill travel 10 mm down and back for each sample tested.

[0167] Prior to testing of a sample, the T-rod 1101 is lowered until itis resting directly on top on one of the supporting rods 1108. Thevertical position of the T-rod 1101 is “zeroed” when the load as itrests on supporting rod 1108 is about 1 gram_(f). The T-rod 1101 is thenraised 5 mm from this zero position and centered between both supportingrods 1108.

[0168] The sample 1000 to be tested can be a piece of material takenfrom one of the flexible extensions. The sample 1000 taken from theflexible extensions should have a dimension of about 25 mm in thelongitudinal direction LD and a dimension in the transverse direction ofabout 10 mm. If the flexible extensions on the product to be tested aretoo small, a larger sample of the same material should be used for thetest. The sample is placed so that the push rod 1103 is running parallelto a side of the sample that was oriented in the transverse directionTD.

[0169] The T-rod 1101 is then allowed to travel through a complete 10 mmcycle (i.e., 10 mm down and 10 mm back up). Consequently, the T-rod 1101will make contact with the sample 1000 after about 5 mm and bend thesample about an additional 5 mm. The bending resistance is the peakforce required to bend the sample as the T-rod travels through acomplete 10 mm cycle.

Burst Strength Test Overview

[0170] A test specimen, held between annular clamps, is subjected toincreasing force that is applied by a 0.625 inch diameter, polishedstainless steel ball. The burst strength is that force that causes thesample to fail. Burst strength may be measured on wet or dry samples.Apparatus Burst Tester Intelect-II-STD Tensile Test Instrument, Cat. No.1451- 24PGB or the Thwing-Albert Burst Tester are both suitable. Bothinstruments are available from Thwing-Albert Instrument Co.,Philadelphia, PA. The instruments must be equipped with a 2000 g loadcell and, if wet burst measurements are to be made, the instruments mustbe equipped with a load cell shield and a front panel water shield.Conditioned Room Temperature and humidity should be controlled to remainwithin the following limits: Temperature: 73 ± 3° F. (23° C. ± 2° C.)Humidity: 50 ± 2% Relative Humidity Paper Cutter Scissors or otherequivalent may be used Pan For soaking wet burst samples, suitable tosample size Solution Water for soaking wet burst samples should beequilibrated to the temperature of the conditioned room. TimerAppropriate for measuring soak time

Sample preparation

[0171] 1) Cut the sample to a size appropriate for testing (minimumsample size 4.5 in×4.5 in). If the sample to be tested is too small(e.g., a flexible extension with overall dimensions less than 4.5 in×4.5in) a larger sample of the same material should be used to determine wetburst strength. Prepare a minimum of five samples for each condition tobe tested.

[0172] 2) If wet burst measurements are to be made, place an appropriatenumber of cut samples into a pan filled with temperature-equilibratedwater.

Equipment Setup

[0173] 1) Set the burst tester up according to the manufacturer'sinstructions. If an Intelect-II-STD Tensile Test Instrument is to beused the following are appropriate:

[0174] Speed: 12.7 centimeters per minute

[0175] Break Sensitivity: 20 grams

[0176] Peak Load: 2000 grams

[0177] 2) Calibrate the load cell according to the expected burststrength.

Measurement and Reporting

[0178] 1) Operate the burst tester according to the manufacturer'sinstructions to obtain a burst strength measurement for each sample.

[0179] 2) Record the burst strength for each sample and calculate anaverage and a standard deviation for the burst strength for eachcondition.

[0180] 3) Report the average and standard deviation for each conditionto the nearest gram.

[0181] Report the average and the standard deviation for each group offour samples.

[0182] This concludes the test.

Water Dispersion Test

[0183] Apparatus Stirrer Magnetic, Thermolyne type Model S7225 or 7200(no substitutions). Permanently inscribe a circle 3.5 inches (8.9centimeter) on the top surface of the stirrer. The center of the circlemust be coincident with the geometric center of the stirrer. StirringBar 2.5 inch (6.2 centimeter) TEFLON coated with spinning ring.Permanently mark one end of the bar with black ink for a distance of 0.5inch (1.2 centimeter) back from the tip. Thermometer 30 to 120° F. with1 degree divisions Timer Digital stopwatch Stroboscope Variable speedstroboscope, model 964 available from Strobette, Power Instrument, Inc.of Skokie, IL is suitable Beaker Kimax brand 2000 milliliter with spout(no substitution), Inscribe a fill mark at a height of 5.6 inches (14.3centimeters) from the flat bottom of the beaker. Do not use any beakernot having a flat bottom. Conditioned Room Temperature and humidityshould be controlled to remain within the following limits: Temperature:73 ± 3° F. (23° C. ± 2° C.) Humidity: 50 ± 2% Relative Humidity

Test Setup

[0184] 1. Fill the beaker to the fill mark with 73±3° F. tap water.

[0185] 2. Place the beaker on the magnetic stirrer centering it in theinscribed circle.

[0186] 3. Add the stirring bar to the beaker.

[0187] 4. Turn the stroboscope on and set the speed to 1000 rpmaccording to the manufacturer's directions.

[0188] 5. Turn the magnetic stirrer on with the on/off switch. Adjustthe speed of the magnetic stirrer until the stirring bar appears to bestationary and both ends appear to be black. This indicates that themagnetic stirrer is turning at 500 rpm (i.e. half the setting on thestroboscope). Turn the magnetic stirrer off with the on/off switch.

Procedure

[0189] 1. Hold a sample (e.g. an absorbent interlabial device 20) 3 to 4inches (7.6 to 10.2 centimeters) above the surface of the water. Gentlydrop the sample onto the water surface, starting the timer when thesample touches the water surface.

[0190] 2. Wait 5 seconds.

[0191] 3. Start the magnetic stirrer with the on/off switch.

[0192] 4. Record the time required until the sample separates into atleast two pieces. If the motion of the stirring bar is disrupted by thesample so it no longer rotates, turn off the magnetic stirrer. Recenterthe magnet without removing the sample and restart the stirrerimmediately. The time recorded is the total time that the sample remainsin the water, including the time required to restart the stirrer.

[0193] 5. Repeat steps 1 through 4 with an additional 3 samples.

Calculation and Reporting

[0194] Calculate and report the mean and standard deviation of the waterdispersibility time for the four samples tested. However, if at leastone of the four samples separates into at least two fragments during thetime specified in the appended claims, the sample will be considered tobe water dispersible. The term “fragments” as used herein, is notintended to include the separation of merely a few loose fibers (thatis, fibers which constitute less than 5% of the total product mass) fromthe sample. The interlabial devices described herein preferably disperseinto at least two fragments within about 1 hour, more preferably withinabout 30 minutes.

[0195] This concludes the test.

Flushability Overview

[0196] As noted above, the terms “flushable or flushability” refer to aproduct's capacity to pass through typical commercially availablehousehold toilets and plumbing drainage systems without causing cloggingor similar problems that can be directly associated with the physicalcharacteristics of the product. For the purpose of the appended claims,catamenial products are evaluated for flushability via relative ease oftoilet bowl and trap evacuation and subsequent transport through asimulated plumbing system. The flushability of such a device should bemeasured by the following test procedure.

[0197] The test procedure is designed to simulate two days of normaltoilet usage for a family of 4 (2 men, 2 women). The test employs aflushing sequence to simulate the following conditions: male urinationvisits, female urination visits (including post urinary drying withtissue), disposal of catamenial product (that is, the interlabial deviceor other device to be tested) with cleaning using tissue, and bowelmovement visits. The amount of tissue to be used for each tissue flushis a normal loading of 2 strips of seven sheets. The normal loading isbased on consumer research regarding typical habits and practices. Thetest is designed to simulate the conditions a product will encounter ifit is flushed through a conventional toilet and into a municipal seweror into a septic tank. Samples are evaluated for: 1) toilet bowl andtrap clearance, 2) drain line blockage, and 3) disintegration duringflushing.

Apparatus

[0198] An apparatus suitable for the flushability test is shown in planview in FIG. 14. The apparatus includes:

[0199] a 3.5 gallon (13.2 liter) water saver siphon vortex toiletreferred to as 210 (additional toilets can also be attached to thepiping layout shown in FIG. 14 to evaluate the behavior of test samplesusing different flushing mechanisms such as commercial, pressuretoilets);

[0200] approximately 59 feet (18 meters) of 4 inch (10 cm) insidediameter acrylic pipe (As can be seen from FIG. 14, the piping isassembled in roughly a square configuration having linear runs 211, 213,215, 217, 219, 221 approximately 10 feet (3 meters) long);

[0201] a cast iron tee 223 slightly downstream of the toilet 210 that isopen to the atmosphere for venting;

[0202] five cast iron ninety degree elbows 212, 214, 216, 218, and 220;

[0203] a snag 222 positioned vertically (FIG. 15) approximately 15 feetfrom the pipe's terminal end and approximately 1 inch (2.5 cm) long; and

[0204] a screen (No. 4 Tyler sieve) to capture solid effluent forevaluation of disintegration.

[0205] The apparatus used for this method is set up to be equivalent toANSI Standard A112.19.2M-1990 for Vitreous China fixtures. The piping isplumbed to provide a drop of 0.25 inch per foot (2 centimeters/meter) ofpipe length.

Materials

[0206] Tissue Product used in Test: standard CHARMIN® toilet tissuemanufactured by The Procter & Gamble Company of Cincinnati, Ohio.

[0207] Synthetic Fecal Material Prepared according to the methoddescribed below

Test Flushing Sequence

[0208] The test flushing sequence simulates 2 days of normal toiletusage for a family of 4 (2 men, 2 women; based on consumer habits andpractices research). The sequence of 34 total flushes consists of 14flushes with an empty bowl, 8 flushes with tissue only, 6 flushes withtissue and a catamenial product and 6 flushes with tissue and simulatedfecal matter (SFM). When it is used, the SFM is placed in the bowl justprior to the addition of tissue. The SFM loading of 160 g±5 g consistsof two 1 inch (2.5 centimeter)×4 inch (10 centimeter) pieces and one 1inch (2.5 centimeter)×2 inch (5 centimeter) piece. Folded tissue strips(or the catamenial product) are placed in the bowl at 10 secondintervals. Ten seconds after the final strip or catamenial product isplaced into the bowl, the toilet is flushed. The flushing sequence isdescribed below as a series of two routines combined in the followingorder:

[0209] Routine #1 (To be performed first 6 times for a total of 30flushes)

[0210] 1) Flush With Tissue Only—Take a drain line blockage reading 2minutes after the water reaches the simulated obstruction, wait 1additional minute, and move to step 2.

[0211] 2) Flush With Empty Bowl. Take a drain line blockage reading 2minutes after the water reaches the snag point and move to step 3.

[0212] 3) Flush With Tissue and Catamenial Product—Take a drain lineblockage reading 2 minutes after the water reaches the snag point, wait1 additional minute, and move to step 4.

[0213] 4) Flush With Empty Bowl. Take a drain line blockage reading 2minutes after the water reaches the snag point and move to step 5.

[0214] 5) Flush With Tissue and Simulated Fecal Matter (SFM). Take adrain line blockage reading 2 minutes after the water reaches the snagpoint, wait 1 additional minute.

[0215] Routine #2 (To be performed 1 time)

[0216] 1) Flush With Tissue Only—Take a drain line blockage reading 2minutes after the water reaches the snag point, wait 1 additionalminute, and move to step 2.

[0217] 2) Flush With Empty Bowl. Take a drain line blockage reading 2minutes after the water reaches the snag point and move to step 3.

[0218] 3) Flush With Tissue Only—Take a drain line blockage reading 2minutes after the water reaches the snag point, wait 1 additionalminute, and move to step 4.

[0219] 4) Flush With Empty Bowl. Take a drain line blockage reading 2minutes after the water reaches the snag point.

[0220] Total number of flushes per sequence is 34.

[0221] If, after the second flush in the flushing sequence, the productremains in the bowl or trap after flushing, the tissue and or catamenialproduct is plunged into the drainage line manually and the flushingsequence will continue. After completion of each trial loading, thedrainage pipe will be cleared prior to beginning subsequent testing.

[0222] The above described flushing sequence is repeated three times foreach test product.

Data Reporting

[0223] The degree of drain line blockage is determined by measuring thelength of water dammed up behind the obstruction. Graduations are markedevery 12 inches (30 centimeters) on the drainpipe upstream of theobstruction. Each one foot length that the water is backed upcorresponds to 0.25 inch (0.6 centimeter) or 6.25% of blockage at theobstruction point. Test product residues which exit the drainpipe arealso collected.

[0224] The following data are recorded for each evaluation:

[0225] 1) Incidence of failure (%) of catamenial product to clear bowland trap in one flush

[0226] 2) Incidence of failure (%) of catamenial product to clear bowland trap in two flushes

[0227] 3) Incidence of product on simulated snag

[0228] 4) Maximum level (%) of drain line blockage

[0229] 5) Cumulative level (%) of drain line blockage over the 2 daysimulated test period.

[0230] Preferably, the products described herein will completely clearthe bowl at least about 70% of the time in two or fewer flushes, morepreferably at least about 80% of the time in one flush, and mostpreferably at least about 95% of the time in one flush. The productsdescribed herein will preferably have a maximum level of drain lineblockage of less than or equal to about 80%. The products describedherein will preferably have a cumulative level of drain line blockageover the 2 day simulated test period of less than or equal to about 50%.

Preparation of Synthetic Fecal Material

[0231] I. Materials Needed:

[0232] Feclone synthetic fecal matter (900 grams); (Available fromSiliclone Studio, Valley Forge, Pa. as product BFPS-7 dry concentrate )

[0233] Tap water at 100° C. (6066 grams)

[0234] II. Equipment Needed:

[0235] Mixer (Available from Hobart Corp., Troy, Ohio as Model A200)

[0236] Extruder (Available from Hobart Corp., Troy, Ohio. as Model 4812)

[0237] Disposable Centrifuge tubes with screw caps (50 ml) (Availablefrom VWR Scientific, Chicago, Ill. as Catalog No. 21-008-176)

[0238] Water Bath to control temperature to 37° C.

[0239] III. Preparation:

[0240] 1. Pour the 100° C. water into the mixing bowl of the mixer andadd the dry Feclone concentrate.

[0241] 2. Mix on low for 1 minute.

[0242] 3. Mix on medium speed for 2 minutes.

[0243] 4. After the material is well mixed, transfer to the extruder.

[0244] 5. Using an ice pick, punch a small hole in the tip of eachcentrifuge tube.

[0245] 6. Extrude the Feclone into the centrifuge tubes.

[0246] 7. Cap the centrifuge tubes and store in the refrigerator.

[0247] 8. Before using, put the tubes in the water bath at 38° C.

Specific Illustrations of the Preparation of Emollient-treatedInterlabial Devices

[0248] The following are specific illustrations of interlabial deviceswith emollient compositions in accordance with the present invention:

EXAMPLE 1

[0249] A. Preparation of Emollient Compositions

[0250] A water free emollient composition (Emollient A) is made bymixing the following melted (i.e., liquid) components together: MineralOil (Carnation White Mineral Oil, USP made by Witco Corp.), CetearylAlcohol (a mixed linear C₁₆-C₁₈ primary alcohol made by the Procter &Gamble Company under the name TA-1618); Steareth-2 (Brij 72, a C₁₈linear alcohol ethoxylate having an average degree of ethoxylation of 2,made by ICI America). The weight percentages of these components areshown in Table I below: TABLE I Component Weight % Mineral Oil 50Cetearyl Alcohol 35 Steareth-2 15

[0251] B. Preparation of Emollient-Treated Interlabial Device by HotMelt Spraying

[0252] Emollient Composition A is placed into a heated tank operating ata temperature of 125° F. The composition is subsequently sprayed (usinga Dynatec E84B1758 spray head, operating at a temperature of 165° F. andan atomization pressure of 2.40 psig) onto the body-contacting surfaceof the interlabial device. Add-on level=2.3 mg/cm²).

EXAMPLE 2

[0253] A. Preparation of Emollient Compositions

[0254] A water free emollient composition (Emollient B) is made bymixing the following melted (i.e., liquid) components together: MineralOil (Carnation White Mineral Oil, USP made by Witco Corp.), and CetearylAlcohol (a mixed linear C₁₆-C₁₈ primary alcohol made by the Procter &Gamble Company under the name TA-1618). The weight percentages of thesecomponents are shown in Table II below: TABLE II Component Weight %Mineral Oil 65 Cetearyl Alcohol 35

[0255] B. Preparation of Emollient-Treated Interlabial Device by HotMelt Spraying

[0256] Emollient Composition B is placed into a heated tank operating ata temperature of 125° F. The composition is subsequently sprayed (usinga Dynatec E84B1758 spray head, operating at a temperature of 165° F. andan atomization pressure of 2.40 psig) body-contacting surface of theinterlabial device. Add-on level=0.006 g/in² (2.3 mg/cm²).

EXAMPLE 3

[0257] A. Preparation of Emollient Composition

[0258] A water free emollient composition (Emollient C) is made bymixing the following melted (i.e., liquid) components together: WhiteProtopet® 1S (white petrolatum made by Witco Corp.), Cetearyl Alcohol (amixed linear C₁₆-C₁₈ primary alcohol made by the Procter & GambleCompany under the name TA-1618); Cetearth 10 (a blend or mixture of C₁₆and C₁₈ alcohols ethoxylated to an average of 10 ethoxylate unitsobtained from BASF Corp. of Mount Olive, N.J.). The weight percentagesof these components are shown in Table I below:

[0259] A water free emollient composition (Emollient C) is made bymixing together the following melted (i.e., liquid) components in theweight percentages shown in the Table III below according to theprocedure of Example 2: TABLE III Component Weight % WhiteProtopet ® 501S Cetearyl Alcohol 35 Cetearth-10 15

[0260] B. Preparation of Emollient-Treated Interlabial Device by HotMelt Spraying

[0261] mollient Composition C is placed into a heated tank operating ata temperature of 125° F. The composition is subsequently sprayed (usinga Dynatec E84B1758 spray head, operating at a temperature of 165° F. andan atomization pressure of 2.40 psig) body-contacting surface of theinterlabial device. Add-on level=0.004 g/in² (1.5 mg/cm²).

EXAMPLE 4

[0262] A. Preparation of Emollient Composition

[0263] A water free emollient composition (Emollient D) is made bymixing the following melted (i.e., liquid) components together: WhiteProtopet® 1S (white petrolatum made by Witco Corp.); Dow Corning 556Cosmetic Grade Fluid(a polyphenylmethylsiloxane made by the Dow CorningCorporation), An example of a particularly preferred paraffin wax isParrafin S.P. 434 (a paraffin wax made by Strahl and Pitsch Inc.);Cetearyl Alcohol (a mixed linear C₁₆-C₁₈ primary alcohol made by theProcter & Gamble Company under the name TA-1618); PEG 2000 ( apolyethylene glycol having a MW of 2000 made by Sigma-Aldrich Corp). Theweight percentages of these components are shown in Table IV below:TABLE IV Component Weight % WhiteProtopet ® 52 1S Polyphenylmethyl- 10siloxane Paraffin Wax 15 Cetearyl Alcohol 20 PEG 2000  3

[0264] B. Preparation of Emollient-Treated Interlabial Device by HotMelt Spraying

[0265] Emollient Composition D is placed into a heated tank operating ata temperature of 150° F. The composition is subsequently sprayed (usinga Dynatec E84B1758 spray head, operating at a temperature of 170° F. andan atomization pressure of 2.40 psig) body-contacting surface of theinterlabial device. Add-on level=0.006 g/in² (2.3 mg/cm²).

[0266] While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention.

What is claimed is:
 1. An absorbent interlabial device for wearing inthe interlabial space of a female wearer, said interlabial device havinga body-contacting surface at least a portion of which is capable ofmaintaining contact with the inside surfaces of the wearer's labia whenthe absorbent device is worn, and an absorbent portion, wherein at leasta portion of said body-contacting surface comprises an emollientcomposition, said emollient composition comprising a substantiallywater-free emollient, said emollient composition being free ofhydrocarbon components having a molecular weight greater than or equalto 1,500, wherein at least a portion of said emollient compositionremains on said body-contacting surface without being absorbed into saidinterlabial device.
 2. The absorbent device of claim 1 wherein saidemollient begins to soften at or below human body temperature.
 3. Theabsorbent interlabial device of claim 1 wherein said emollient has aplastic or liquid consistency at 20° C.
 4. An absorbent interlabialdevice for wearing in the interlabial space of a female wearer saidinterlabial device having a body-contacting surface at least a portionof which is capable of maintaining contact with the inside surfaces ofthe wearer's labia when said device is worn, and an absorbent portion,wherein at least a portion of said body-contacting surface comprises anemollient composition which is liquid, semisolid, or solid at 20° C.,wherein said emollient composition comprises a substantially water freeemollient having a plastic or liquid consistency at 20° C. andcomprising a member selected from the group consisting ofpetroleum-based emollients, fatty acid ester emollients, alkylethoxylate emollients, and mixtures thereof
 5. The absorbent device ofclaim 4 wherein said emollient contains about 5% or less water andcomprises a petroleum based emollient selected from the group consistingof mineral oil, petrolatum, and mixtures thereof
 6. The absorbent deviceof claim 4 wherein said emollient composition comprises: (i) from about10 to about 95% of a substantially water free emollient having a plasticor liquid consistency at 20° C. and comprising a member selected fromthe group consisting of petroleum-based emollients, fatty acid esteremollients, alkyl ethoxylate emollients, and mixtures thereof, and (ii)from about 5 to about 90% of an agent capable of immobilizing saidemollient on said body-contacting surface, said immobilizing agenthaving a melting point of at least about 35° C.
 7. The absorbent deviceof claim 6 wherein said emollient contains about 5% or less water andcomprises a petroleum based emollient selected from the group consistingof mineral oil, petrolatum, and mixtures thereof
 8. The absorbent deviceof claim 7 wherein said emollient is petrolatum.
 9. The absorbent deviceof claim 7 wherein said emollient is mineral oil.
 10. The absorbentdevice of claim 6 wherein said immobilizing agent is selected from thegroup consisting of polyhydroxy fatty acid esters, polyhydroxy fattyacid amides, C₁₄-C₂₂ fatty alcohols, C₁₂-C₂₂ fatty acids, C₁₂-C₂₂ fattyalcohol ethoxylates, waxes, and mixtures thereof.
 11. The absorbentdevice of claim 4 wherein the quantity of emollient composition on saidbody contacting portion of said absorbent device ranges from about 0.1mg/cm² to about 30 mg/cm².
 12. The absorbent device of claim 11 whereinthe quantity of emollient composition on said body contacting portion ofsaid absorbent device ranges from about 1 mg/cm² to 15 mg/cm².
 13. Theabsorbent device of claim 6 wherein said emollient composition comprisesfrom about 5 to about 50% of said immobilizing agent, said immobilizingagent having a melting point of at least about 40° C.
 14. The absorbentdevice of claim 13 wherein said immobilizing agent comprises a C₁₄-C₂₂fatty alcohol.
 15. The absorbent device of claim 14 wherein saidimmobilizing agent comprises a C₁₆-C₁₈ fatty alcohol selected from thegroup consisting of cetyl alcohol, stearyl alcohol, and mixturesthereof.
 16. The absorbent device of claim 6 wherein said immobilizingagent comprises a paraffin or microcrystalline wax.
 17. The absorbentdevice of claim 4 wherein said emollient composition further comprisesfrom about 1 to about 50% of a hydrophilic surfactant, said hydrophilicsurfactant having an HLB value of at least about
 4. 18. The absorbentdevice of claim 6 wherein said emollient composition further comprisesfrom about 1 to about 50% of a hydrophilic surfactant, said hydrophilicsurfactant having an HLB value of at least about
 4. 19. The absorbentdevice of claim 18 wherein said emollient composition further comprisesfrom about 1 to about 25% of said hydrophilic surfactant, saidhydrophilic surfactant being nonionic and having an HLB value of fromabout 4 to about
 20. 20. The absorbent device of claim 19 wherein saidhydrophilic surfactant comprises an ethoxylated alcohol having an alkylchain of from about 8 to about 22 carbon atoms and having an averagedegree of ethoxylation ranging from about 1 to about
 54. 21. Theabsorbent device of claim 20 wherein said ethoxylated alcohol has analkyl chain of from about 11 to about 22 carbon atoms and having anaverage degree of ethoxylation ranging from about 2 to about
 30. 22. Anabsorbent interlabial device insertable into the interlabial space of afemale wearer said interlabial device having a body-contacting surfaceat least a portion of which is capable of maintaining contact with theinside surfaces of the wearer's labia when the device is worn, saidinterlabial device comprising: a main absorbent portion comprising anupper portion comprising part of said body-contacting surface and alower portion, said upper portion facing toward the vestibule floor ofsaid wearer during insertion into said interlabial space and leadingsaid lower portion during insertion therein, said lower portion beingopposed to said upper portion and upon insertion of said absorbentdevice into said interlabial space said lower portion facing away fromthe floor of the vestibule of said wearer; and a pair of flexibleextensions joined to said upper portion of said main absorbent portionand extending downwardly and outwardly therefrom, said flexibleextensions comprising part of said body-contacting surface, wherein atleast a portion of said body-contacting surface comprises an effectiveamount of a emollient composition which is semi-solid or solid at 20° C.and which is partially transferable to the wearer's skin, said emollientcomposition comprising a substantially water free emollient having aplastic or liquid consistency at 20° C. and comprising a member selectedfrom the group consisting of petroleum-based emollients, fatty acidester emollients, alkyl ethoxylate emollients, and mixtures thereof 23.The absorbent device of claim 22 wherein said portion of saidbody-contacting surface that comprises said emollient composition issaid upper portion of said main absorbent portion.
 24. The absorbentdevice of claim 22 wherein said portion of said body-contacting surfacethat comprises said flexible extensions is said upper portion of saidmain absorbent portion.
 25. The absorbent device of claim 22 whereinboth said upper portion of said main absorbent portion and said flexibleextensions comprise said emollient composition.
 26. An absorbentinterlabial device which fits at least partially within a femalewearer's labial vestibule, said interlabial device having abody-contacting surface, wherein at least a portion of said absorbentdevice is capable of maintaining contact with the inside surfaces of thewearer's labia when said device is worn, and an absorbent portion,wherein at least a portion of said body-contacting surface comprises aneffective amount of a emollient composition which is semi-solid or solidat 20° C., said emollient composition comprising a substantially waterfree emollient having a plastic or liquid consistency at 20° C. andcomprising a member selected from the group consisting ofpetroleum-based emollients, fatty acid ester emollients, alkylethoxylate emollients, and said absorbent interlabial device has acapacity of greater than or equal to about 2.5 grams of saline when saiddevice is measured under 0.25 psi of pressure.
 27. The absorbent deviceof claim 26 having a capacity greater than or equal to about 4.0 gramsof saline.
 28. The absorbent device of claim 27 further comprising anon-ionic surfactant thereon.
 29. An absorbent interlabial deviceaccording to claim 1 that is sufficiently flushable that it completelyclears the bowl under the Flushability Test at least about 70% of thetime in two or fewer flushes.
 30. An absorbent interlabial deviceaccording to claim 1 that is sufficiently flushable that it completelyclears the bowl under the Flushability Test at least about 95% of thetime in one flush.
 31. An absorbent interlabial device according toclaim 1 which disperses into at least two fragments as measured by theWater Dispersion Test in less than or equal to about one hour.
 32. Anabsorbent interlabial device according to claim I wherein said emollientcoating comprises a multi-component emollient composition having atleast one component with a peak heat absorption of less than 37° C.